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Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Under the supervision of a Senior Specialist, Manager, or Associate Director, the Maintenance Scheduler is responsible for building effective maintenance schedules that can be efficiently executed by the maintenance team, to minimize operational downtime and maximize mechanic productivity. The Scheduler provides strategic scheduling support for assigned area, which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or support utilities including power, HVAC, steam, WFI and controlled temperature units. The maintenance scheduler role is predominantly forward-looking and seldom becomes involved in work execution. The scheduler will work collaboratively with all stakeholders, drive work prioritization, and engage the proper resources to create maintenance schedules for all planned Preventative, Predictive and Corrective work orders, that can be executed right first time. The scheduler actively ensures GMP quality, safety, environmental, and operating cost goals are achieved, and may sometimes provide supervisory coverage of hourly mechanic workforce to ensure supply of a high quality product. DUTIES: <ul><li>Work with business stakeholders and work order requesters to gather maintenance schedule inputs. Specifically, work with maintenance planner(s) for work ready to be scheduled, with maintenance supervisor(s) for labor availability, with manufacturing scheduler(s) for equipment availability</li><li>Align work ready to be scheduled with equipment availability and available labor to build maintenance schedules looking ahead 1-4 weeks</li><li>Build maintenance schedules for planned shutdown periods</li><li>Establish or adopt scheduling standard work; tasks include but are not limited to: refresh and communicate maintenance backlog to all stakeholders, lead scheduling meeting, publish/finalize work schedule, generate KPIs</li><li>Drive work prioritization based on compliance requirements, work order due dates, business needs, cost, and backlog management</li><li>Relay request for supplementary labor needs to maintenance supervisor as required</li><li>Execute work order or CMMS/CCMS administration tasks, such as initiation, review, approval, and closure, as required</li><li>Generate KPIs related to maintenance scheduling and work execution. Present KPIs to stakeholders; analyze KPIs and implement continuous improvement to scheduling process</li><li>Proficient in all GMPs, safety, and environmental regulations</li><li>Assist in audits, regulatory inspections and training in the area of responsibility</li></ul> Education Minimum Requirement: <ul><li>B.S. or B.A.</li></ul> Required Experience and Skills: <ul><li>Two (2) years of experience in one or a combination of the following: manufacturing, project management, technical support, administration, coordination, or planning</li><li>The maintenance scheduler is highly organized, analytical, motivated to drive positive change, and is capable of being influential outside of his/her functional group</li><li>Experienced in using Computerized Management Maintenance Systems, Excel, SAP, or equivalent database/spreadsheet systems</li><li>Proficient in the following competencies: communication, teamwork/collaboration, problem solving, empowering leadership, flexibility</li></ul> Preferred Education, Experience and Skills: <ul><li>4 year technical or engineering degree.</li><li>Working Knowledge of cGMPs for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management) and CMRP certification desired.</li></ul>VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/22/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328998

public

EM&U Scheduler

Job Description As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for biologically derived drug substances (e.g., therapeutic proteins, antibody drug conjugates, or vaccines) generated from bioconjugation processes. For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing. This role may also require approximately 25% of time spent on domestic (e.g. to Rahway, NJ site) or international travel. In this role, the successful candidate will be responsible for: <ul><li>Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance / bioconjugation processes. </li><li>Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally.</li><li>Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.</li><li>Authors experimental protocols and documents work in a lab notebook.</li><li>Documents lab activities, findings and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.</li><li>May be responsible for managing multifaceted projects as the leader of a cross-functional team. As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team.</li></ul> Education & Experience: <ul><li>Bachelor's Degree in Engineering, Science, or related field with a minimum of four (4) years of large molecule/anti-body drug conjugate and/or commercialization experience; OR</li><li>Master's Degree with a minimum of three (3) years of large molecule/anti-body conjugate experience; OR</li><li>Doctoral Degree (Ph.D.) with no (0) years of experience.</li></ul> Required Skills and Experience: <ul><li>Experience with large molecule manufacturing processes including on-the-floor GMP manufacturing support</li><li>Experience designing process development experiments using risk-based methodology or similar</li><li>Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization</li><li>Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other regulatory source documentation</li><li>Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors</li><li>Possesses outstanding communication skills</li><li>Ability to coach others and manage small teams effectively</li></ul> Preferred Skills and Experience: <ul><li>Experience with bioconjugation or antibody drug conjugate processes</li><li>Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites</li><li>Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar</li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/16/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R327108

Senior Scientist, Engineering

Job Description 2025 University Recruiting - Process Research Co-ops The Future Talent Program features co-ops that last up to 6 months and will include one or more projects. These opportunities in our Research & Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our company's Research Lab's Process Research Departments are seeking co-ops with a passion for scientific research, strong academic performance, communication skills, and the ability to work on cross-functional teams. We offer opportunities in our state-of-the-art science laboratories to solve fundamental synthetic or biological problems relevant to drug development, while functioning as fully integrated members of the company project teams. Process Research Co-op: Rahway, NJ The candidates will work alongside company scientists in an organic synthesis laboratory to invent novel chemical reactions relevant to the synthesis of drug-like molecules (e. g. small molecules, cyclic peptides, and bioconjugates). Day-to-day research for the co-ops will focus on solving key challenges in reaction design utilizing the latest advances in organic synthesis. In addition to the development of synthetic routes to potential drug candidates, co-ops may focus/engage in bio- and chemocatalysis screening and development, laboratory automation, flow chemistry, labeled compound synthesis, and data science and informatics. Candidates will participate in departmental and project team meetings to provide a broad perspective on the development process in the pharmaceutical industry. Co-ops will also gain skillsets via exposure to practical aspects and day-to-day problems of pharmaceutical research. Co-ops will be responsible for and trained in methods for accurate electronic notebook recording and safe laboratory practices. In addition, they will have an opportunity to present their research results in both oral and written formats. **Please note when applying for this position, if the candidate is selected for an interview, the applicant must be prepared to submit letters of recommendation, a brief research statement, and a copy of transcripts. **Please note that visa sponsorship for this position is not available. Candidates must be able to provide proof of work authorization in the U.S. if they are offered the position. Required Education & Experience: <ul><li>Candidates must be currently enrolled as a sophomore, junior, or senior student pursuing a Bachelor's degree in Chemistry OR currently enrolled as a graduate student pursuing a Master's or Ph.D. in Chemistry.</li><li>Candidates must have completed at least two years of studies toward a bachelor's degree by June 2025.</li><li>Candidates must be available to work full-time for approximately 4-6 months in 2025</li></ul> Preferred Experience & Skills: <ul><li>Candidates should have a significant interest in organic chemistry</li><li>Candidates should have basic laboratory skills and preferably previous research experience that includes the use of various experimental techniques, electronic notebook recording,</li><li>Candidates should have a GPA of 3.0 or higher</li></ul>FTP2025 MRL2025 Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Yes Job Posting End Date: 01/15/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326588

2025 University Recruiting - Small Molecule Process Research & Development Co-op

Job Description Global Project and Alliance Management (GPAM) sits in the R esearch & D evelopment Division at our Company (known as our Company Research Laboratories). The Project Managers in GPAM are core members of development teams at our company , driving these cross-functional teams to deliver projects and products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project & Portfolio management functions which support Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of this individual will be to lead project management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to Supply , driving line of sight across the development lifecycle and maintaining programs in harmony with the portfolio . In addition, the Associate Director will be expected to participate in development of tools and processes to support holistic portfolio management and increased integration of CMC and Clinical strategies . Position Description/Summary: The CIPM Associate Director, Project Manager , is a core member of DCTs , partnering with team lead s to develop strategies and execute our Company's drug and vaccine development efforts to progress the R&D pipeline . The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and proficiency in project management to take on challenging assignments with minimal guidance. Projects could span the full CMC development continuum from Line of Sight to First in Human to Transfer to Supply stage-gates . This position may be based in either Rahway , NJ or Upper Gwynedd , PA . Primary Responsibilities: <ul><li> Manag e the end-to-end CMC development process , including projects of significant complexity; driv e cross- functional teams and lead by influence to develop comprehensive strategies and ensure successful execution. </li><li> Act as an enterprise leader by g uiding teams through the creation, approval, and execution of integrated project plans appropriate to the p roject's phase of development and complexity . Drive development of a CMC strategy that is optimized for the portfolio. </li><li> Build and maintain project schedules and critical project information , u s ing these tools to integrate activities across key functional areas , proactively identify risks, and ensure c lear and effective communication with key team, management, and cross-departmental stakeholders . </li><li> Leverag e relationships and networks to improve and enhance team dynamics , proactively identifying and removing obstacles to drive business results. </li><li> Navigat e our Company process and organizational norms to enable teams to understand corporate governance and business requirements , thereby enabling informed decision-making. </li><li> Lead key team meetings including creating thoughtful agendas, ensuring appropriate participation , contributing project management insights, and following up to ensure the team continues to make progress while holding others accountable . </li><li> Participate in CIPM and GPAM departmental initiatives and workstreams aimed at improving the way that we work and the way that we interact with one another as well as other departments. </li><li> Provid e mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects , s haring lessons learned and best practices to positively impact the community . </li><li> Support multiple projects providing team management, stakeholder management, and governance preparation support to DCT teams . </li></ul> Required Education, Experience, and Skills: <ul><li> Bachelor's degree required ; concentration in a scientific or applied discipline preferred </li><li> Minimum of five (5) years of experience in project management or a related role required </li><li> Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing, or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas. </li><li> Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate) , and management fully apprised of project initiative status and issues at the right level of detail </li><li> Demonstrated ability to serve as a resource for colleagues and program teams. </li><li> Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas. </li><li> Ability to succeed in a dynamic environment with flexibility to respond to changing priorities </li></ul> Preferred Experience and Skills: <ul><li> Advanced scientific degree (e.g., MS, MBA, Ph.D. , PharmD) preferred </li><li> Experience and knowledge of clinical drug development strongly preferred; including the different phases of development and how the various functional areas contribute to a comprehensive strategy </li><li> Project management certification (PMP) and/or formal coursework/training in project management strongly preferred </li></ul>#eligibleforERP GPAMjobs #EBRG #VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/11/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R327093

Associate Director, Project Management, Chemistry Manufacturing Controls (CMC) - Hybrid

Job Description The Associate Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing intermediate and final product samples. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as sterility bioburden, and endotoxin. The successful candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. Primary Responsibilities: The emphasis is on microbiological methods, such as sterility, endotoxin, and bioburden.<ul><li>Has knowledge of cell aseptic technique and standard microbiological procedures for BSL-1 and BSL-2 laboratories</li><li>Perform data review of laboratory test data and associated records</li><li>Trouble-shoots equipment issues as needed</li><li>Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions</li><li>Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements</li><li>Provides active support during audits and inspections (regulatory, internal, safety)</li><li>Supports our Company's Manufacturing Division (MD) divisional and Quality initiatives</li></ul>Education Minimum Requirement:<ul><li>B.S. degree in a science field required, preferably biology, microbiology, or biological sciences</li></ul>Required Experience and Skills:<ul><li>Good technical writing skills and high attention to detail</li><li>1 year of laboratory testing or equivalent educational laboratory</li><li>Work independently and within a team environment</li><li>Good communication</li><li>Aseptic techniques</li><li>Schedule - 5-day work week will include either Saturday or Sunday has the potential to transition into 4-day/10-hour work week including either Saturday or Sunday.</li></ul>Preferred Experience and Skills:<ul><li>Knowledge of cGMP and cGDP</li><li>Experience handling and manipulating BSL-1 and BSL-2 microorganisms</li><li>Compendia microbiological testing methods</li><li>Bioburden testing</li><li>Sterility testing</li><li>Endotoxin (LAL) testing</li><li>Growth Promotion</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EBRG VETJOBS #EBRG VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Yes Job Posting End Date: 01/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R308592

Associate Specialist, Quality -Durham, NC

Job Description GENERAL SUMMARY : Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine. The Senior Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing of the BCG Product. Initially the position will focus on microbiology and sterility testing readiness in preparation for commercial production. The selected candidate will initially work on assay development, assay validation, equipment validation, and GMP laboratory readiness. The Senior Specialist, Quality Control will be responsible for starting testing in new laboratories using principles of our Production Systems, Lean Laboratories, and GMP requirements. At the completion of assay development and qualification, the Senior Specialist, Quality Control will execute routine testing of new and or existing products, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support. The selected candidate will support the sterility and microbiology testing laboratories with emphasis on microbiological methods (such as microbial enumeration, bacterial endotoxin, sterility). The analyst will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understand of Labware LIMS, handle Quality Notification authoring and provide audit support. GENERAL PROFILE: <ul><li>Collaborate with internal customers and vendors to identify, evaluate, and implement new analytical technologies that expand site capabilities. Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.</li><li>Build knowledge of the company, processes, and internal/external customers</li><li>Build and maintain strong relationships with site leadership, stakeholders, and customers</li><li>Build relationships to work in a highly functioning diverse team environment</li><li>Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals</li><li>Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing</li><li>Capability to function effectively within an automated/electronic laboratory environment</li><li>This position will be located at the Durham, NC site. Short periods of travel may be required as needed for training. </li></ul> BUSINESS EXPERTISE: <ul><li>Understands the fundamental business drivers for the company; uses this knowledge in own work</li><li>Understands and applies regulatory/ compliance requirements relative to their role</li><li>Influence, motivate, and energize individuals at all levels in the organization</li></ul> FUNCTIONAL EXPERTISE: The Senior Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to include the following:<ul><li>Lead for microbiology and sterility assay qualification, including but not limited to microbial enumeration testing, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.</li><li>Microbiology and sterility routine testing, including but not limited to microbial limits, endotoxin, rapid microbiology methods, compendial sterility testing and non-compendial sterility testing.</li><li>Schedule daily testing of laboratory samples based on internal metrics and production needs.</li><li>Author/review technical documents, method transfer/qualification reports, standard operating procedures, change controls, and investigations for the performance of laboratory methods</li><li>Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions</li><li>Execute test method qualification</li><li>Trouble-shoot method and equipment issues as needed</li><li>Sample management</li><li>Planning and test method execution to meet established delivery timelines</li><li>Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning</li><li>Train and mentor laboratory analysts on test methods, techniques, and good documentation practices.</li><li>Review of laboratory generated data and results</li><li>Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures</li><li>Provide active support during audits and inspections (regulatory, internal, safety)</li><li>Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations</li><li>Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements</li><li>Influence, motivate, and energize individuals at all levels in the organization</li><li>Support Divisional and Quality initiatives.</li><li>Additional project and routine testing support as required by vaccine analytical testing requirements</li><li>Other duties as requested by management to support effective laboratory operations and performance metrics</li></ul> PROBLEM SOLVING: <ul><li>Identifies and solves a range of problems in straight forward situations; analyzes possible solutions and assesses each using standard procedures</li></ul> INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS: <ul><li>Responds to standard requests from internal and external customers</li></ul> IMPACT :<ul><li>Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition</li><li>Influence and Decision Making:</li><li>Represents Quality in the laboratory to influence cGMP compliance and ensure product quality</li><li>Explains information and persuades others in straightforward situations</li><li>Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines</li><li>Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality</li></ul> PROJECT MANAGEMENT: <ul><li>Accountable for quality and/or technical contribution to project team or sub-team</li><li>Support project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing</li></ul> RESOURCE MANAGEMENT: <ul><li>Aware of costs and assists in controlling costs related to own work</li></ul> QUALIFICATIONS : Required<ul><li>B.S. or M.S. degree in Biological Sciences, with minimum of 5 years of laboratory experience</li><li>Experience with aseptic manipulations</li><li>Exceptional pipetting techniques</li><li>Good technical writing skills and high attention to detail.</li><li>Experience with execution and trouble-shooting of cell based and other microbiological/biological assays.</li><li>Previous GMP-laboratory experience</li><li>Work independently and within a team environment</li><li>Sterility testing (compendia or rapid microbiological methods) experience</li><li>Experience with compendial microbiological testing such as (USP Chapters , , and )</li><li>Experience with assay development, validation, or technical transfers</li></ul>Preferred:<ul><li>Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).</li><li>Equipment Validation</li><li>Root cause analysis methodology</li><li>Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry</li><li>Experience in regulatory agency audits and/or regulatory filings</li><li>Experience in technical writing, including Standard Operating Procedures and method transfer/qualification reports</li></ul> PHYSICAL REQUIREMENTS: <ul><li>Ability to sit, stand and move within work space for extended periods</li><li>Ability to work standing in a laboratory environment for extended periods</li><li>Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling</li><li>Ability to travel</li></ul> WORKING RELATIONSHIPS: <ul><li>Reports to Microbiology Manager</li><li>Interacts with employees within own department</li><li>Frequent interaction with employees from other departments and across our sites</li><li>Interacts with representatives from regulatory agencies</li><li>Interacts with external suppliers</li></ul>Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. #EBRG VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/23/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R322564

Sr. Specialist, Quality Control

Job Description Job Description We are seeking a highly skilled Security Architect with a strong background in designing resilient and highly available cloud-hybrid systems. In this role you will be responsible for working with business and technology architects and IT leaders to help drive technology optimization, align teams to overall Security and Compliance Strategy and drive technology and architecture blueprints re-use. The ideal candidate would be self-driven and able to work with little supervision. Key responsibilities:<ul><li>Design and Implementation: Designing robust and scalable cloud-hybrid systems that ensure high availability and resilience in a medium to large organization.</li><li>Oversee PoCs and discovery efforts: Help initiating, driving or overseeing PoC and discovery efforts allowing the company to protect against emerging threats and address controls deficiencies</li><li>Defining Security architecture principles, patterns and blueprints: Prepare reusable architectural artifacts in the form of design diagrams, IaC or infographics.</li><li>Strategic alignment: Collaborate with cross-functional teams to influence and define roadmaps and strategies, ensuring alignment with organizational strategy and company's goals.</li><li>Stakeholder Engagement: Build and maintain strong interpersonal relationships, leveraging exceptional networking and influencing skills to navigate cross-culturally with a diverse range of stakeholders, both internally and externally.</li><li>Train & educate technical architects on security best practices and broker knowledge sharing within the Security Architecture community.</li></ul>Required Experience and qualification:<ul><li> Bachelor's degree in Computer Science, Mathematics, other relevant engineering discipline </li><li>Experience working in a large enterprise, driving outcomes by influencing various IT and business teams, business and technology architects, IT and divisional leaders.</li><li>Experience working within a Scaled Agile Framework (SAFe), Product Model and Agile teams.</li><li>Proven Expertise in Security Architecture and Threat Modeling: Demonstrated experience in designing and implementing security architectures, particularly within hybrid environments that integrate on-premises and cloud solutions. Ability to assess risks and develop strategies to mitigate threats effectively.</li><li>Strong understanding of core IT Security disciplines: Knowledge of IAM, Network Security, Endpoint Security, Security Operations, Risk and compliance</li><li>Strong Grasp of Architectural Principles and Technologies: Deep familiarity with modern architectural methodologies including serverless architectures, microservices, and the principles of DevSecOps. Ability to leverage these technologies to deliver innovative and effective security solutions that align with business goals.</li><li>Analytical and Problem-Solving Skills: Exceptional analytical skills coupled with a strong aptitude for problem-solving. A proactive mindset focused on innovation and the continuous improvement of security practices.</li><li>Effective Communication and Collaboration Skills: Excellent verbal and written communication abilities, allowing for effective collaboration with both technical teams and non-technical stakeholders. Capable of educating teams on complex security concepts in a clear and concise manner.</li></ul>Preferred experience and qualification:<ul><li>In-Depth Understanding of Modern Security Paradigms: Comprehensive knowledge of contemporary security approaches, such as Zero Trust architecture, to ensure robust security in digital environments.</li><li>Hands-On Experience with Cybersecurity Standards and Frameworks: Practical application of established cybersecurity standards and frameworks, including NIST Cybersecurity Framework (NIST CSF), Center for Internet Security (CIS) Critical Security Controls, ISO 27000 series, and NIS2 Directive, to enhance organizational security posture.</li><li>Training and certifications aligned with the job description<ul><li>e.g. ISC2 CISSP certification</li><li>e.g. GIAC relevant certifications</li><li>e.g. ISACA CISM or CISA</li><li>e.g. CCSK or Cloud Architecture Certifications (AWS, Azure, GCP)</li></ul></li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $139,600.00 - $219,700.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/29/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R330076

Associate Director for Architecture, IT Risk Management and Security (ITRMS)

Job Description The Virology Customer Representative is a key member of the Customer Team and plays a critical role in supporting our Company's customer centric business model. This role is responsible for working with the Customer Team to understand and identify customer needs, supporting pull-through activities relative to the customer strategy, keeping with our Company's values and standards as governed by our policies and ensuring that our Company is viewed as demonstrating better health outcomes to healthcare professionals and their patients. The Virology Customer Representative demonstrates professionalism and leadership by modeling the required knowledge for successful execution of all Field Sales competencies. Territory Information: <ul><li> This position is responsible for covering the Washington D.C. mirror territory, which also includes the Metro D.C. area. </li><li>This position will share territory coverage with another Virology Customer Representative.</li><li> The ideal location to reside is within this territory or within a reasonable commuting distance to workload center. </li><li> Travel (%) varies based on candidate's location within the geography. </li></ul> Primary Responsibilities include and may not be limited to: <ul><li> Communicates product information in a way that's meaningful and relevant to each individual customer; customizes discussions and client interactions based on understanding of customer's needs. </li><li> Engages in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information. </li><li> Within select customer accounts, acts as primary point of contact for customer, meets with key customers/personnel to understand practice structure, business model, key influencers (IDS, ADAP, DOC, VAs, DOH)/network structure, customer needs and identifies business opportunities. </li><li> For select customer accounts/HCPs, coordinates with customer team to develop customer strategy - outlining strategy for interactions/ relationship, solutions and potential offerings for customer. </li><li> Shares learnings and best-practices from one customer to help other customers meet their needs. </li><li> Demonstrates a focus on better health outcomes (considers the HCP & patient experience). </li><li> Provides input into resource allocation decisions across customers. </li><li> Identifies and selects programs/services available in the library of our "resources" to address customer needs. </li><li> Maintains current understanding of practice structure, business model, key influencers/ network structure and makes information available to relevant stakeholders. </li><li> Influences beyond their specific geography or product area. </li><li> Embraces and maximizes new technological capabilities and channels to engage customers. </li><li> Engages in all job responsibilities and activities with the highest standards of ethics and integrity, with particular emphasis on compliance with all relevant laws, policies and regulation. </li></ul> Virology Specific: <ul><li> The Virology Customer Representative demonstrates the ability to execute at each stage of the sales process. He/she creates a compelling and logical rationale in positioning our Company's Virology products versus the competition by focusing on appropriate patient types and use of supportive approved resources. </li><li> Demonstrates the ability to stay ahead of market trends, assesses impact of dynamics on current business state and makes proactive recommendations to meet the future needs of the business. Demonstrates innovation, resilience and is able to adapt to ambiguous/evolving business environments. </li><li> Demonstrates advanced ability to ask strategic, insightful questions to obtain information on customer healthcare needs. Uses the insights to position Virology products and collaborates with customers on focused and customized business strategy. </li><li> Demonstrates the ability to identify customer/market segments and industry conditions in local market. Special emphasis on Specialty Pharmacy to leverage business opportunities and understanding of Virology products distribution channels/challenges. </li><li> Demonstrates the ability to drive results by appropriately managing the total Virology product portfolio by prioritizing individual opportunities and plan execution through customer segmentation, targeting and business analysis. </li><li> Articulates the complexities of the HIV payer environment, recognizing the role each stakeholder plays in the ability to access our company's Virology product portfolio. </li><li> Demonstrates the ability to apply understanding of account needs and inter-dependencies in order to develop and execute account plans. Collaborates and models teamwork with extended members of the Virology Account Team (CLs, CTLs, Managed Care, Marketing) in the development of long-term account plans and customer centric solutions to improve value for both customers and patients. </li><li> Demonstrates the ability to embrace and maximize current and future technological capabilities and multi-channel opportunities to engage customers. </li><li> Demonstrates high-level collaboration skills to optimally maximize customer interactions and territory management with cross-functional Virology and non-Virology stakeholders such as Community Liaisons, IDS executives, fellow District members etc. </li><li> Demonstrates the ability to forge and manage business relationships with difficult to access customers in a no sample" environment. </li><li> Demonstrates ability to function effectively and employ a business owner mindset" during business cycles undergoing a high degree of change, including flexing across customer segments, product portfolios, and working in flexible matrix configurations. </li><li> Demonstrates high-level compliance with all Company policies and procedures. </li></ul> Qualifications: Minimum Requirements: <ul><li> Bachelor's Degree with 2-6 years sales experience or a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices). </li><li> Valid driver's license and ability to drive a vehicle. </li><li> Ability to travel within the territory to visit with customers in-person and for national sales meetings, conferences, etc. </li></ul> Preferred Qualifications: <ul><li> Minimum of two (2) years working in one or more of the following areas: account management or sales experience working with Infectious Disease customers, with a preference for HIV product experience and/or launch experience. </li><li> Preference for specialty sales experience across multiple specialty markets with a preference for launch experience. </li><li> Experience in pharma, biotech or medical device sales. </li><li> Demonstrated experience developing and executing plans for engaging customers and meeting customer needs. </li><li> Demonstrated success in establishing, developing and maintaining relationships. </li><li> Prior experience working in a highly regulated industry or environment where compliance to laws and policies is critical. </li><li> Account experience working in complex hospital systems, teaching Institutions and community hospitals. </li><li> Demonstrated skill set to identify account inter-dependencies and build partnerships with key stakeholders/departments. </li><li> Experience with complex payer environments, recognizing the role each stakeholder plays in the ability to access the product portfolio, especially pharmacy stakeholders. </li><li> Current disease state customers acknowledge individual as a trusted and reliable representative. </li><li> Experience interacting with scientific thought leaders and developing advocates across an adoption continuum. </li><li> Demonstrated ability to develop customer relationships in a challenging-to-access or no sampling" environment. </li><li> High level of business acumen and account management skills. </li><li> Current relationships with key opinion leaders within designated account preferred. </li><li> Leadership, planning and organization, self-motivation and initiative, ability to learn, understand and convey complex information. </li><li> Understanding of the value and importance of approaching job responsibilities with ethics and integrity and working in a highly compliant environment. </li></ul>#USPharma Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $101,100.00 - $159,100.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 01/11/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326386

Virology Customer Representative - Washington D.C. Mirror

Job Description Activities Develops program and study-level feasibility and operational parameters : Via analysis of evidence, uses, and may develop, specialized methodology to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Collaborates with CSSM to align on deliverables. (25%) Develops and recommends program and study-level recruitment and retention plan: Develops study-level patient outreach and recruitment vendor strategies, and, in collaboration with CSSM PL or SM, develops implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%) Project management of Recruitment Tactics: the Sr. GTOS creates an execution plan for program and study-level recruitment and retention tactics. Includes country specific details and ranges of contribution for each tactic. In collaboration with program, study leads manage the implementation of these tactics especially related to recruitment and media vendors. (30%) Personal and Professional Development: Attends training and conferences in Patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to bear on the GTO function. (10%) Contributes to training, and process improvement: Provides leadership to less experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods and guides others re: application of informatics, simulation, and modeling. Provides training on systems and tools which support Global Trial Optimization activities; inclusive of applications of performance metrics for Global Trial Optimization in order to leverage internal and external intelligence and support/refine methods and tactics on assigned projects. Maintain relationships with system and tool vendors and research new tools to enhance data capabilities. (10%) Impact: Under the supervision of their manager, the Sr. GTOS identifies for the CSSM organization strategies and tactics that will be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our clinical trials. Participates in early identification of potential risks to those objectives. Participates in developing and implementing mitigation strategies when needed. Collaborates with manager to align the operational execution plan with divisional scorecard objectives. Decision Making: The Sr. GTOS conducts operational analyses and planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with their management chain, the GTOS finalizes deliverables and identifies potential areas for process improvement. Problem Solving: The Sr. GTOS must have strong analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. They must be able to negotiate and influence stakeholders. Assessing the gaps between desired and feasible operational outcomes of clinical development programs, developing solutions to these, and then successfully promoting them are key skills. Expertise: The Sr. GTOS should possess a Bachelor or Master of Science degree in medical/pharmaceutical/biological sciences with at least 5 years of career experience including 3-5 years' experience in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment. Leadership: The Sr. GTOS must be able to communicate and express ideas clearly, orally and in writing, to develop operational parameters, Recruitment and retention plans and other key GTO deliverables. They will represent GTO, with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review. They must be able, with appropriate support, to influence team colleagues through data driven argument. In general, will collaborate with the appropriate manager as they prepare for LDRC/EDRC review. Influence / Liaison: The Sr. GTOS will be a representative to support to other division functional areas in the education and methodology of feasibility and patient recruitment science and a trusted resource to operational field personnel implementing and managing recruitment and retention tactics at the site level. The GTO outputs for which a GTOS is responsible drive Clinical supply planning, timing and feasibility assessment of clinical programs and studies, and LDRC contract dates. Education Minimum requirement <ul><li> Bachelors Degree (Life-science related) </li><li> 5 years of clinical trial related experience (Experienced in feasibility or recruitment with a developing skill set in strategic contributions that exceed trial level contributions) </li></ul>#eligibleforerp ResearchanddevelopmentGCTO Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $111,400.00 - $175,300.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/11/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R326728

Sr. Scientist, Clinical Operations (REMOTE)

Job Description The Associate Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing intermediate and final product samples. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as sterility bioburden, and endotoxin. The successful candidate will also be expected to review and authorize testing results, collaborate in day-to-day lab scheduling, provide leadership in lean lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. Primary Responsibilities: The emphasis is on microbiological methods, such as sterility, endotoxin, and bioburden.<ul><li>Has knowledge of cell aseptic technique and standard microbiological procedures for BSL-1 and BSL-2 laboratories</li><li>Perform data review of laboratory test data and associated records</li><li>Trouble-shoots equipment issues as needed</li><li>Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions</li><li>Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements</li><li>Provides active support during audits and inspections (regulatory, internal, safety)</li><li>Supports our Company's Manufacturing Division (MD) divisional and Quality initiatives</li></ul>Education Minimum Requirement:<ul><li>B.S. degree in a science field required, preferably biology, microbiology, or biological sciences</li></ul>Required Experience and Skills:<ul><li>Good technical writing skills and high attention to detail</li><li>1 year of laboratory testing or equivalent educational laboratory</li><li>Work independently and within a team environment</li><li>Good communication</li><li>Aseptic techniques</li><li>Schedule Monday through Friday, 1st shift.</li></ul>Preferred Experience and Skills:<ul><li>Knowledge of cGMP and cGDP</li><li>Experience handling and manipulating BSL-1 and BSL-2 microorganisms</li><li>Compendia microbiological testing methods</li><li>Bioburden testing</li><li>Sterility testing</li><li>Endotoxin (LAL) testing</li><li>Growth Promotion</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. #EBRG VETJOBS Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Yes Job Posting End Date: 01/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R315708

Job Description The Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules and biologics, as well as creating and maintaining reference data utilized across the company. The incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills, and project management skills to derive high-quality reference data to meet the diverse needs of the business in a timely manner. Primary activities include, but are not limited to:<ul><li>Creating and maintaining reference data and chemical nomenclature throughout the lifecycle</li><li>Entering reference and nomenclature data into a centralized database</li><li>Performing data integrity review activities, including proofreading</li><li>Developing rules to ensure data quality</li><li>Contributing as a key player to discussions relating to the evolving standards of reference data and chemical nomenclature</li><li>Leading nomenclature and reference data projects or other data management tasks</li><li>Facilitating timely delivery of high-quality scientific nomenclature to meet the diverse needs of the business</li><li>Supporting maintenance and testing for the reference data systems, including SDLC</li><li>Identifying opportunities to improve efficiency, effectiveness and quality and implement changes</li><li>Building and maintaining excellent relationships with end users/stakeholders, including outreach and engagement</li><li>Identifying, evaluating, and/or developing new reference data sources</li><li>Demonstrating knowledge of company policies and procedures governing information disclosure</li></ul>Chemical Nomenclature<ul><li>Leveraging knowledge of IUPAC and CAS nomenclature to assign chemical names to small molecules and biologics</li><li>Researching existing chemical names for accuracy</li><li>Maintaining up to date knowledge of IUPAC and CAS standards and rules</li></ul>Reference Data<ul><li>Utilizing knowledge of the drug development process and of master data principles for small molecules, biologics, vaccines, devices to assign company identifiers and descriptive metadata</li><li>Maintaining current knowledge of data standards for pharmaceutical products, such as IDMP ISO standards for identifying medicinal products and WHO Drug Dictionary</li><li>Maintain pharmaceutical product reference data (non-company)</li></ul>Qualifications: Education:<ul><li>Degree in chemistry, chemical engineering, or related scientific discipline plus relevant pharmaceutical/biotech industry experience - Bachelor's and 8+ years, Master's and 6+ years, PhD and 3+ years</li></ul>Required: Chemical Nomenclature<ul><li>Completed at least one year of organic chemistry coursework</li><li>Knowledge and experience with chemical nomenclature (IUPAC or CAS style), structures, and stereochemistry</li><li>Experience with structure drawing software (ChemDraw, ACD, etc.)</li><li>Reference Data</li><li>Knowledge or experience with terminology (dictionaries, thesauri, taxonomies, ontologies) or reference/master data standards (U.S. and/or international)</li><li>Experience with master data management systems, content, and processes</li><li>Experience in master data management, data standards and business rules, provenance and stewardship</li><li>Experience with biomedical and/or chemical searching resources (SciFinder, STN, Medline/PubMed, Dialog, etc.)</li><li>Familiarity with small molecules, biologics, and vaccines</li><li>Broad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated environment</li><li>Ability to engage stakeholders to determine reference/master data requirements in support of their business needs, and deliver the data solution</li><li>Excellent written and verbal communication skills with the ability to convey technical and business information</li><li>Strong prioritization and project management skills, with high attention to detail</li><li>Ability to work effectively in a matrix environment</li><li>Ability to work independently to drive tasks to completion and to act with appropriate accountability</li><li>Excellent customer service orientation with prompt response to inquiries</li><li>Ability to present in a group environment</li><li>Ability to work under pressure in a changing environment with flexibility</li><li>Proficiency with Microsoft Office products, especially Excel</li></ul>Preferred:<ul><li>Knowledge of database structure and available tools to manage, extract, and report data</li><li>Computer programming skills (i.e., XML, Python, etc.)</li><li>Knowledge of text mining, machine learning, natural language processing, and data visualization</li><li>Database searching skills (i.e. SQL)</li><li>Familiarity with ontologies and data standards relevant to the biomedical industry (e.g. GO, MedDRA, CDISC, MESH, UMLS, HL7, WHO-Drug and ATC classes, IDMP)</li><li>Experience designing and developing taxonomies, reference data or controlled vocabularies</li><li>Familiarity with medical devices</li><li>Experience with FAIR principles and other standards</li><li>Experience writing and maintaining process documentation</li><li></li></ul>#eligibleforERP Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $135,500.00 - $213,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/10/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R324696

Associate Director, Scientific Nomenclature and Reference Data

Job Description Job Description: The Director of US Hub Programs, Patient Access COE, will provide strategic input and share the management of a $32M (and growing) annual portfolio of Hub programs in the US, including new programs for launch products. The Director is responsible for understanding and aligning to individual brand strategy and to identify and recommend solutions for addressing barriers to patient access. The solutions must (1) align with divisional objectives (2) comply with our company's policies and procedures and (3) be appropriately accounted for with respect to financial and government reporting. Primary Responsibilities and Activities include: <ul><li>Provide the strategic framework and guidance in the development and deployment of patient access and support hubs" for specialty products, including for upcoming US launches of our company's products</li><li>Build and manage relationships with vendors who will perform benefits investigations and other related support to help ensure that patients and health care providers understand coverage and to assist patients with affordability options for our company's medications</li><li>Work with Our Company's Patient Assistance Foundation to ensure consistent PAP referral business rules</li><li>Primary Budget Point & Quarterly Business Reviews/Quarterly Key Results Point for the Patient Access COE</li><li>Work closely with legal and regulatory departments to ensure compliance with internal and external rules for all programs.</li><li>Exhibit ownership and accountability for all projects and internal assignments</li><li>Development of annual strategies and tactics plan, seeking input and guidance from brand team; provide ongoing strategic support to brand teams</li><li>Engage with US Commercial teams to educate them on the potential shape of such programs, determine what features are important and feasible, select, contract and set up programs with vendors, work with legal, and other parts of the organization as needed. </li><li>Manage Associate Directors and consultants assigned to US Hub programs.</li></ul> Qualifications: Education Minimum Requirement: <ul><li>BA/BS degree</li></ul> Required Experience and Skills: <ul><li>Minimum of 3 years in Pharmaceutical Marketing or Sales, Pricing, Reimbursement or Access, Legal, Finance or related fields supporting Pharmaceutical Marketing and Sales</li><li>Ability work hybrid and come into the North Wales (Upper Gwynedd), PA office at least 3 days per week</li><li>Expertise in vendor management, including budgeting, contracting, audits, financial reporting, general operations, IT, SOP/business rule auditing and strategic thinking</li><li>Mastery of our company's internal processes and policies, particularly around compliance and Medical/Legal review of materials, reimbursement and related policies</li><li>Excellent written and verbal communications skills, proven leadership and interpersonal skills, and proficiency in leading cross-functional teams</li><li>Experience with the US pharmaceutical market, including understanding of various types of customers, pharmaceutical vs medical benefit</li><li>Strong consulting and collaboration skills</li><li>Strong project management skills</li></ul> Preferred Experience and Skills: <ul><li>Experience with US Patient Support Programs</li><li>Oncology, Immunology and/or PAH experience</li><li>People management skills</li></ul> Travel: Up to 20% Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/17/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R329504

Director of US Hub Programs, Patient Access COE

Job Description Our Company a global healthcare leader, is seeking an Associate Principal Scientist to join our collaborative, dynamic, and inclusive Laboratory Animal Resources Team at the West Point, PA, USA location. The successful candidate will be integral in developing research models in rodents and non-rodents, as well as some routine veterinary and animal colony management tasks. This dynamic role will involve supporting preclinical projects across our Company's Research portfolio in early discovery and in the GLP environment. On-site and hands-on study-related lab work will be a crucial part of the role. Additionally, the individual will collaborate cross-functionally with ongoing in vivo discovery research and development projects, as well as initiate, develop, and implement special projects to facilitate advancements in laboratory animal care or use that align with ophthalmic research requirements. It is crucial for this individual to exercise care to ensure both personnel safety and animal welfare. The role also requires occasional on-call rotation weekend support, and the ability to apply sound technical skills to assigned tasks, often with minimal supervision. Responsibilities: Team player who is a creative, independent thinker, thrives in a widely interdisciplinary environment, and enjoys working closely and communicating effectively with colleagues in extremely diverse fields. Experience working with various species in the laboratory animal field providing scientific and technical support to biomedical research projects, collaborating with researchers and research staff, training and teaching research and lab animal staff, and ensuring compliance with federal, state, and local regulations and AAALACi standards. Willingness to perform, refine and develop existing and new surgical modes in various preclinical species. Provide excellent preventative, clinical, diagnostic, and surgical care and services to a diverse, dynamic, AAALACi-accredited animal research institution. Collaborate cross-functionally with principal investigators, scientific staff, toxicologists, pathologists, veterinarians, veterinary technicians, IACUC members, facility managers, and animal care technicians. Maintain accurate, timely, and well-organized records of animal treatments, study data, procedures, inventories, research protocols, and reports in both non-GLP and GLP platforms. Independently recognize study/project hurdles (operational, technical and scientific) and propose solutions. Train veterinary and technical staff on various handling and clinical procedures as they relate to laboratory animal medicine. Advise investigators regarding animal model selection or development. Develops novel approaches to establish unique animal models as required. Communicate any project work, study results, and data interpretation to cross-functional project teams as needed. Comply with US and company-specific rules and regulations, e.g., Animal Welfare Act, The Guide, 3Rs principles, FDA and other regulatory bodies. Qualifications: Required:<ul><li>You hold a Doctor of Veterinary Medicine (DVM, VMD or equivalent) from an AVMA-accredited or recognized school of veterinary medicine.</li><li>Completed a residency in Laboratory Animal Medicine.</li><li>You will have strong interpersonal and communication skills.</li><li>You will have experience in building and leading teams, managing people and animal research facilities.</li><li>Demonstrable passion for animal care and welfare.</li><li>Willingness to learn technical and scientific skills and a comprehensive understanding of the R&D process.</li><li>Initiative seeking, innovative, and solution-oriented mindset.</li><li>Excellent organizational, interpersonal, and communication skills.</li><li>Commitment to maintaining highest safety and regulatory standards.</li><li>Ability and readiness to participate in weekend on-call rotation schedule.</li></ul>Preferred:<ul><li>Diplomate of ACLAM or ACLAM board-eligible.</li></ul>Our Company values collaboration, coordination, and communication. We aim to foster an atmosphere of mutual respect and provide a vibrant learning environment where new skills can be honed, and innovative solutions can be explored. If you are interested in contributing to our research within a dynamic team that prioritizes respect and collaboration, we would love to hear from you. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/24/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R309337

Associate Principle Scientist - Veterinarian

Job Description The Executive Director, Manufacturing Alliance Management and Integrations is responsible for leading the strategy, development, and management of strategic partnerships, alliances, and integrations driving realization of deal value as part of the company's One Business Development (BD) process. The manufacturing alliances may range from licensing, supply, distribution, co-marketing, divestitures, joint ventures and other business collaborations resulting from deals initiated by Corporate or Global/Market BD and Manufacturing driven BD deals aligned with the company's strategic goals. The incumbent will provide leadership and guidance to their global staff across all phases of the alliance management and integration life cycle as well as due diligence primarily in support of local and global deals as required. The leader will represent our company's Manufacturing Division on strategic alliance matters with internal and external stakeholders enabling refinement of alliance strategies and driving efficient and effective business processes leveraging the Division's tools and resources in a fit for purpose compliant manner. The leader will collaborate closely with Corporate, Research, and Human Health (HH) Alliance Management, Enterprise Integration functions, manufacturing functional areas (e.g., External Manufacturing, Supply Chain Management, Quality, Science & Technology, and Manufacturing Operations) and business partners in support functions (e.g. Legal, Finance. HR where applicable) on a regular basis to achieve business priorities. The scope of responsibilities will include: <ul><li>Provide leadership on all global, regional, and local Manufacturing Alliance Management activities for our company's Manufacturing Division across all technology platforms supporting our human health business.</li><li>Leads or guides contractual governance bodies aligned with internal decision-making groups impacting our alliance partners.</li><li>Ensures the management of alliances by establishing and maintaining effective business processes to assure high customer service levels, promote positive relations, and advance the objectives with the alliance partner while working within the terms and conditions of existing agreements.</li><li>Ensure that integration processes align with the company's strategic objectives and facilitate seamless transitions during mergers and acquisitions.</li><li>Provides input/support to business development transaction team that has a manufacturing/supply component.</li><li>Ensures that new business development deals are effectively transitioned and integrated into routine alliance management and integration processes.</li><li>Collaborates with functional areas (Supply Chain, Quality, Technical operations, External Manufacturing, and Manufacturing Operations) to resolve supply issues, identify and mitigate risks, and identify opportunities, including escalation and report outs to senior management.</li><li>Tracks key performance indicators such as delivery performance and quality performance for review with partner on routine basis for continuous improvement. Works with the partner to resolve any supply issues; ensures corrective actions are identified and implemented to ensure reliable supply.</li><li>Represents our company externally in partnership with enterprise alliance management groups increasing positive understanding of our company's alliance management organization in support of future business deals.</li><li>Assures organization operates within established corporate & divisional policies & procedures.</li><li>Develops & manages annual Profit Plan including but not limited to payroll, travel, project, and discards.</li><li>Recruits, manages and develops a global team of professionals across wide range of disciplines.</li><li>Organizational management includes staffing, resourcing, performance management and talent management.</li></ul>The position will report to the Senior Vice President of Manufacturing Strategy, Business Development and Alliance Management. The leader will have accountability for realizing material value potential for the manufacturing division and company through complaint, reliable, collaborative manufacturing alliances and effective integration execution by interfacing across the operating units, markets and functions in delivering on these potentials. Education Minimum Requirement:<ul><li>Bachelor's degree in Science, Engineering, Supply Chain Management, or related disciplines; Master's Degree preferred</li></ul>Required Experience and Skills: <ul><li>Minimum 15 years Bio-pharmaceutical Manufacturing Operations, Supply Chain Management, Quality, Science and Technology, Global Procurement, External Manufacturing, Alliance/Partner Management or related transferrable experiences </li><li>Negotiation and contract management skills</li><li>Strong relationship building skills and networking skills with external partners</li><li>Leadership of global direct and indirect teams, working across multiple cultures</li><li>Strong commitment to Diversity and Inclusion</li><li>Strong financial and business acumen</li><li>Excellent communication and presentation skills</li><li>Innovative thinking to resolve, prevent or mitigate manufacturing issues</li><li>Familiarity with quality and regulatory expectations</li></ul>Preferred Experience and Skills: <ul><li>Advanced scientific degree or life sciences background/experience </li><li>Familiarity with contract law and/or commercial law</li><li>Familiarity with business development</li><li>Knowledge of our company's Manufacturing Division's organization and processes</li></ul>Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $206,200.00 - $324,600.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/21/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328849

Executive Director, Manufacturing Alliance Management and Integrations

Job Description Our Research Scientists are our Inventors. We translate molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. Our company's Sterile Product Development department is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining primary packaging / device. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. We are seeking a motivated engineer / scientist to work collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new biological / chemical entities as part of a matrix team from initial first-in-human formulations to commercialization. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Additional Responsibilities:<ul><li>Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to develop sterile drug products.</li><li>Capable of learning practical laboratory / pilot plant skills and fundamental scientific principles to utilize as part of their daily responsibilities.</li><li>Executes routine experiments and data interpretation with appropriate technical guidance. Operates and troubleshoots equipment and processes.</li><li>Builds capability to support manufacturing operations in GXP environments.</li><li>Can understand overall project timelines to manage prioritization of individual contributor deliverables with appropriate supervision.</li><li>Works well with others in collaborative team environments.</li><li>Takes initiative, motivated to excel, has a strong technical background, has excellent communication and interpersonal skills.</li><li>Builds awareness of relevant new and current technologies to grow as a pharmaceutical scientist.</li></ul>Education Minimum Requirements: <ul><li>B.S. degree in Chemical / Biochemical / Biomedical Engineering, Materials Science, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields (or an expected graduation date on or before May 2025)</li></ul>Required Experience and Skills:<ul><li>Strong verbal and written communication skills.</li><li>Strong collaboration skills and experience working in a team environment.</li><li>Ability to learn and apply new scientific principles to execution of daily responsibilities.</li><li>Demonstrated ability to collate and conduct basic data analysis.</li><li>Prior experience with Microsoft Office.</li></ul>Preferred Experience and Skills: <ul><li>Prior experience in a laboratory environment.</li><li>Passion to learn and develop as a pharmaceutical scientist.</li></ul>#eligibleforerp #vetjobs #EBRG Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected US salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here . San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/11/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R328336