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We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. JOB SUMMARY The Regulatory Operations Specialist will be an integral member of the Global Regulatory Operations Team, providing support with various ongoing submissions to remain in compliance with all FDA and other U.S. and international regulatory requirements and company standards. The qualified candidate will be responsible for supporting the compilation of regulatory submissions in eCTD format and providing support in the Emergent Regulatory Information Management System (RIM) under the oversight of the Senior Manager (or Manager), Regulatory Operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The main duties and responsibilities include but are not limited to: &bull; Track and compile regulatory submissions from electronic sources; assemble, and publish submission documents in accordance with established timelines, global regulations, and relevant company procedures &bull; Review published submissions prior to filing to a Health Authority &bull; Interact with internal regulatory staff and external vendors to facilitate on-time publishing and submission of regulatory documents &bull; Assist in the development, implementation, and maintenance of document standards, templates, and procedures related to the formatting and publishing of electronic submissions and best practices in the Emergent RIMS. &bull; Participate on project teams as Regulatory Operations representative &bull; Support document migration as a part of potential company integration activities &bull; Format MS Word documents that have been provided by Regulatory Affairs according to the Emergent Style and Formatting guide standards. &bull; Format PDF files to ensure that they meet company-defined standards for submission, such as PDF version, bookmarks, links, OCR, etc. &bull; Manage multiple requests, meeting all timelines, and ensuring all updates are captured The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS &bull; B.Sc. or B.A. or a college diploma program with specialized training in Regulatory Affairs &bull; Minimum of 3+years of experience in publishing global submissions required, biological and vaccine products preferred. &bull; Experience with DocuBridge submission publishing and Veeva document management preferred. International publishing experience preferred. &bull; Experience in Formatting documents in Microsoft Word &bull; Strong written and verbal communications. Strong interpersonal skills. Ability to establish sound professional relationships. &bull; Ability to solve routine problems with minimal supervision &bull; Ability to manage multiple submission publishing jobs effectively &bull; Technical ability to understand data object associations and data flow. &bull; Careful attention to detail and accuracy required. If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $101,000 to $122,300] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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Specialist, Regulatory Affairs Operations - Remote

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I: Job Summary We are looking for a manager of accounting, focused on Technical Accounting and Accounting Policy workstreams. This person will be responsible for doing hands on technical accounting research, drafting memorandums and maintaining corporate accounting policies. II: Responsibilites &bull; Perform technical research on complex accounting and reporting topics and prepare documentation around the reporting under US GAAP &bull; Draft and maintain global accounting policies &bull; Review all lease transactions and ensure compliance under ASC 842 &bull; Review material revenue contracts and ensure compliance under ASC 606 &bull; Keep business partners abreast of developments in accounting and financial reporting and related company policies and positions through review of various publications, training sessions, and other forums &bull; Provide support to external auditors during audits and interim reviews. Coordinate requests new and challenging areas and manage the flow of information and documentation. &bull; Assist with the maintenance and updating of Sarbanes-Oxley 404 processes and procedures. &bull; Assist with SEC reporting, including preparation and review of Form 10-K and 10-K disclosures, footnotes, and tie-outs. &bull; Other special projects and duties as requested or assigned The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills &bull; BA/BS degree or equivalent &bull; CPA Big 4 or large national accounting firm experience &bull; 5-8 years of relevant experience from public accounting and/or dynamic, public, multinational, and technology focused companies &bull; Experience working in a technical accounting or similar role &bull; Excellent understanding of GAAP accounting principles, with a strong knowledge of SEC reporting regulations, lease accounting, stock-based compensation, and revenue accounting principles &bull; Strong analytical skills. &bull; Excellent project management, oral communication, analytical and written skills &bull; Interpersonal skills & personnel management skills, attention to detail, organized and thorough with the desire for continuous improvement IV: Physical/Mental Requirements Type/keyboard, use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, and prepare written communications. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $117,500 - $142,100. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.

Manager, Technical Accounting & Policy (Remote)

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I: Job Summary Position supports the management of the monthly, quarterly, and annual close & consolidation process; including preparation of financial information for all SEC, statutory reporting, tax filings and internal management reports. II: Responsibilites <ul> <li>Coordinate the monthly global accounting close process ensuring timely and accurate reporting. Ensure effective use of technology and business process management for the financial statement reporting process.</li> <li>Support and encourage the use the data analytics to perform accounting analysis.</li> <li>Responsible for accounting, review and approval of certain corporate general ledger activity and balances, especially payroll and other compensation-related accruals </li> <li>Liaising with key contacts during the quarter to continually assess and address issues that may result in delays or inaccuracy of information. </li> <li>Prepare the monthly internal financial statements for review and analysis. </li> <li>Ensure journal entries related to consolidation adjustments are complete and accurate. Assist in the preparation and review of financial press releases and SEC financial statement filings on Forms 10-Q and 10-K. Assist with the preparation and review of earnings release, Audit Committee, and compensation committee financial information.</li> <li>Oversee compliance with other governmental reporting requirements</li> <li>Implement new accounting software and technology as necessary to enhance the proficiency of the corporate consolidations team as necessary.</li> <li>Coordinate with external auditors to ensure the completion of financial statement audits and quarterly reviews</li> <li>Coordinate with internal auditors regarding Sarbanes-Oxley Section 404 compliance </li> <li>Coordinate financial reporting to support the tax filing and review process for all federal, state and local income tax activities. Review ASC 740 reporting and disclosures.</li> <li>Support the preparation of statutory reporting filings.</li> <li>Work with FP&A and IR to ensure alignment of financial information reported. Perform data extraction and financial statement reconfiguration as necessary.</li> <li>Manage ongoing government financial reporting compliance requirements. </li> <li>Other projects as assigned, including review of potential acquisitions, provide information for financing activities, and conduct research for new and proposed management initiatives and compliance with new accounting standards.</li> </ul>The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills &bull; Bachelor's degree in Accounting, Finance, Business or related major required; MBA or Master's in a related major preferred &bull; CPA required &bull; 5-7 years of experience &bull; Knowledge in working with ERP systems (SAP a plus) &bull; Software implementation experience &bull; Strong written and verbal communication skills &bull; Strong analytical skills &bull; Experience in GAAP and financial statement preparation PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mental Demands: ☒ Ability to organize/coordinate ☒ Comprehend and follow instructions ☒ Problem Solve ☒ Analyze/Interpret data and information ☒ Perform with frequent interruptions ☒ Make decisions using sound judgment If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [ $117,500 to $142,100] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Manager, Financial Accounting and Consolidations (Remote)

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY The CMC Lead - Drug Development is responsible for establishing the CMC development plan, working with cross-functional experts, and leading the execution of the plan for drug substance and drug products from pre-clinical through commercial development. This role is a key leadership function in the development of therapeutic candidates and advancement of platforms, combined with the introduction of new candidates and technology enhancements for programs within Emergent. The role will deliver on all CMC aspects of a specific project, working both internally, across Emergent's global locations, and externally with partners, contractors and government agencies, to fulfill drug development stages up to and including the coordination of drug substance (upstream & downstream), drug product, and associated analytical development activities through a lead intermediary. The role requires proficiency in advancing the development of our portfolio of vaccine and therapeutic candidates with an ability to oversee programs from the completion of product feasibility through process and product development, scale-up and registration in commercial manufacture. These programs may be a mix of early-stage proof of concept, through IND, late stage, through regulatory approvals, as well as life cycle management programs that require flawless execution because they are critical to commercial success. The role requires strong project coordination and communication skills along with skills in presentation, and leadership, process design, technology transfer, and production of biologics drug supplies along with lifecycle support. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. &bull; This role works cross-functionally to develop strategies, set direction, plan, and prioritize initiatives that lead to the advancement of our project portfolio. This includes the: integration of the work priorities with other groups internal and external to the organization; Effective communication on such initiatives with senior leaders, peers, staff, and external stakeholders. &bull; Leads cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Select third-party manufacturers working with Quality and Regulatory, negotiate effective technical agreements, and identify contract analytical laboratory sites through development to commercialization stages. &bull; Resource planning including budget and staffing model preparation (for departments, functions, or systems) and capacity monitoring of routine operations and enhancement projects. &bull; Manage (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands. &bull; Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND and NDA filings for the products that they manage. &bull; Develop, set, and communicate sustainable targets and goals for self and programs. &bull; Ensure the technology transfer of developed processes to external Contract Manufacturing Organizations (CMO) for GMP clinical manufacturing or additional as may be required. &bull; Be a key member in delivering the company's product portfolio, including participation in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups. &bull; Work closely with the Grants & Contracts team to respond to RFPs and win external funding as may be required. BEHAVIORS: To perform the job successfully, an individual should demonstrate the following competencies: &bull; Leadership -Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Provides vision and inspiration to peers and subordinates; Gives appropriate recognition to others. &bull; Managing across reporting structure - Includes personnel in planning, decision-making, facilitating and process improvements; Takes responsibility for team members' activities; Develops team members' skills and encourages growth; Fosters quality focus in others; Sets expectations and monitors delegates activities; Provides recognition for results. The role places a heavy reliance on the incumbents influencing skills across a range of functions for successful project delivery. &bull; Problem Solving - Identifies and resolves problems in a timely manner, analyzing information skillfully; Develops alternative solutions; Uses reason even when dealing with emotional topics. &bull; Interpersonal - Focuses on solving conflict, not blaming; Maintains confidentially; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. &bull; Teamwork - Balances team and individual responsibilities; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives. &bull; Business Acumen and Ownership - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition. Aligns work with strategic goals; works within approved budget; Develops and implements cost saving measures; Conserves organizational resources. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS &bull; PhD or MS in Chemistry, biological or medical sciences, biotechnology (or a related scientific discipline) with a minimum of 10 years+ experience in the development of therapeutic candidates is desirable. &bull; Experience in biotech/pharma industry at a senior level; 8+ years' experience in a management role; Broad knowledge of biologics and therapeutics. &bull; Direct experience with generating documentation for regulatory filings for drug development. &bull; Experience preferred in the pharmaceutical or biotechnology industry with systems and processes stated coupled with a broad exposure to established and novel drug platforms is preferred. &bull; Proven leadership (in-person and remotely) of a technical team, including all aspects of performance management. &bull; Proven ability to direct internal and external development activities with cross-functional partners and/or external vendors to drive project completion under rigid timelines. &bull; Expert knowledge of scientific principles and concepts in plasma protein, cell culture, purification of protein therapeutics etc. &bull; A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity &bull; Excellent organizational ability and working well in a fast-paced, team-oriented, collaborative way is required. &bull; Excellent communication skills and strong interpersonal skills. &bull; Highly organized, with exceptional time management and prioritization &bull; Critical thinking evaluation of process problems &bull; Strong work ethic &bull; Flexibility to travel on company business when required. If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $192,500 to $233,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Director, CMC Lead Drug Development

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY Based in Emergent's Legal Department, the Sr. Counsel, Data Privacy/ Data Privacy Officer is a newly created position that will work closely with legal, business, compliance and technology teammates to ensure the company's compliance with current/developing rules and regulations. This position is responsible for leading Emergent's data privacy program, including driving understanding of and compliance with U.S. and international privacy laws. This role has global impact across the products and services that the company provides. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Serve as primary privacy contact for internal stakeholders regarding data privacy incidents, inquiries from governing regulatory bodies, conducting data privacy impact assessments (DPIA), data subject access requests, maintaining the Company's privacy policy and third-party data risk assessments, among other duties;</li> <li>Maintain subject matter expertise in multiple areas of privacy, including United States and international data privacy frameworks, regulations and requirements and ability to drive compliance;</li> <li>Responsible for implementing and managing company-wide privacy program. Assess and drive further development of company's privacy program, ensuring Emergent meets its legal, regulatory, and reputational responsibilities, including translating legal requirements into privacy program deliverables and processes; </li> <li>Manage and lead the implementation of the global training and communication programs and monitor privacy risk across the business while also providing updates to internal clients on changes in legal developments in the area of data protection, security, data governance and privacy.</li> <li>Manage cross-functional partnerships with information security colleagues, including Chief Information Security Officer;</li> <li>Lead cross-functional privacy efforts including the identification of and mapping of applicable regulatory obligations to risks, controls, controls testing and policy documents; </li> <li>Lead the DPIA review process and identify potential improvements including enhancing the workflow for the intake, monitoring and tracking of assessments, as well as developing key metrics; </li> <li>Provide oversight for the strategic review, drafting and negotiating of privacy and data security terms in contracts, including data processing agreements and data transfer agreements;</li> <li>Provide oversight and support to the team in partnering with the business and support functions to conduct analyses of the key personal data processing of their areas, including documentation of data flows, processes and procedures while providing risk and controls knowledge to the team to improve business compliance; </li> <li>Develop and implement policies and procedures for privacy compliance processes in support of our privacy strategy; </li> <li>Manage incident response for data privacy breaches, conduct root cause analyses, and oversee remediation efforts;</li> <li>Develop and leverage key performance indicators to track, manage, measure and report on metrics across the organization related to key privacy and compliance trends; and </li> <li>Implement appropriate data privacy compliance controls and tools, including working with compliance technology support and other internal functions to make improvements and address any gaps identified. </li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Minimum 8 years of data privacy compliance and/or legal experience in-house, at a privacy regulator, a law firm, and/or in the government; </li> <li>Law degree and/or equivalent relevant experience is preferred </li> <li>Substantial subject matter expertise in US and international data privacy laws, rules, regulations, and industry standards, including sound working knowledge of EU GDPR as well as expertise in privacy risk and compliance management; </li> <li>Ability to work independently and effectively manage and prioritize multiple projects simultaneously; </li> <li>Maintain industry certification in privacy such as CIPP-US;</li> <li>Experience with NIST Privacy and Cybersecurity frameworks;</li> <li>Experience in identifying, assessing and working with stakeholder groups to mitigate identified risk (across different functions and levels of the business); </li> <li>Ability to work collaboratively in a fast-paced environment in cross-functional teams, prioritize and meet deadlines; </li> <li>An ability to and experience with advising senior business leaders and boards of directors on data privacy matters; </li> <li>Strong stakeholder management experience and skills to collaborate effectively with IT, commercial leads, security and risk professionals, engineers, software developers, product development, Human Resources, and other teams;</li> <li>Strong attention to detail and excellent organizational skills.</li> <li>Team player with the ability to build relationships, internally and externally. </li> <li>Self-motivated and able to motivate others. </li> <li>J.D. preferred but not required</li> </ul>IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical/Mental Demands and Work Environment Characteristics: Mental Demands: <ul> <li>Ability to organize/coordinate </li> <li>Comprehend and follow instructions</li> <li>Direct, control and plan </li> <li>Problem Solve </li> <li>Analyze/Interpret data and information </li> <li>Perform with frequent interruptions </li> <li>Make decisions using sound judgment</li> </ul>Physical Demands:<ul> <li>Use keyboard/computer/phone </li> </ul>Travel:<ul> <li>Occasional travel as required </li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [ $194,500 to $235,900] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr. Counsel, Data Privacy/Sr. Data Privacy Officer

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. JOB SUMMARY The Senior Scientist is a member of a research group supporting internal product development and exploratory research and discovery programs. The Senior Scientist will be responsible for generating stable cell lines and research cell banks as well as contributing to process optimization. The Senior Scientist will also assist in the development and execution of cell-based immunoassays. ESSENTIAL FUNCTIONS Reasonable accommodation will be made to enable individuals with disabilities to perform the essential functions. &bull; Designs experiments for the development of cell lines and optimization of cell line production processes; analyzes the data from such experiments and participates in the formulation of conclusions and next steps. &bull; Assists teammates with the development and execution of immunoassays to measure the productivity of cell lines as well to determine the function of polyclonal antibody responses &bull; Develops and executes cell-based immunoassays &bull; Executes workflows to establish stable cell lines &bull; Develops and maintains cell cultures and cell banks &bull; Write and review technical reports, research protocols, SOPs, and scientific manuscripts for publication. &bull; Serves as lead for tech transfer of cell culture processes to internal departments &bull; Works with a high degree of independence to execute R&D projects and contribute to project planning &bull; Writes and executes experimental protocols for developing/optimizing cell line development processes. &bull; Trouble-shoots and maintains cell culture systems &bull; Analyze data and interpret results. Present and discuss results of experiments with the department and project teams. &bull; Trains other members of the team in techniques. &bull; Safely handle serum and/or tissues from preclinical studies (ie murine, NHP) as well as samples of human origin &bull; Works with BSL-2 reporter viruses under a BSC The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS &bull; PhD in virology, immunology, or a related scientific discipline with a minimum of 5 years of post-doctoral experience &bull; MS with 8 years of experience in vaccine/drug development in an industry research environment. &bull; BS with 10 years of relevant experience in vaccine/drug development in an industry research environment. &bull; Experience working under a Quality Management System &bull; Hands-on experience with Beacon Optofluidic systems &bull; Hands-on experience with Ambr bioreactors is preferred &bull; Broad experience developing and implementing cell-based neutralization assays using BSL-2 pathogens and reporter gene systems &bull; Safely handle BSL-2 organisms and tissue samples &bull; Hands-on experience with high-throughput assay formats and liquid handling &bull; Hands-on experience with automated cell imaging equipment &bull; Hands-on experience with transducing cells via electroporation or chemical transfection &bull; Able to learn new skills quickly &bull; Understanding of scientific methods and statistical analysis &bull; Ability to analyze complex data and reach valid scientific conclusions &bull; Excellent verbal and technical writing skills &bull; Capable of searching scientific literature to gain information about specific topics &bull; Plan project tasks effectively, prioritize, keep to timeline, and multi-task If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $117,500 to $142,100 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Sr. Scientist

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I: Job Summary The Custodian and Grounds Technician is responsible for maintaining all non-GMP areas of the interior/exterior facility in a clean, healthy, audit ready state. II: Responsibilities<ul> <li>Clean all administrative and common areas: empty garbage, clean floors, dust, clean windows, etc. as required.</li> <li>Perform scheduled and unscheduled preventative maintenance tasks in SAP related to cleaning.</li> <li>Maintain detailed cleaning logs for all areas of responsibility.</li> <li>Perform snow removal and landscaping assignments, as required. </li> <li>May oversee contractors employed to perform the general maintenance and repairs to the facility and grounds. </li> <li>Maintain all material, supplies and equipment used to maintain the facility.</li> <li>Participate in and maintain all required job specific and safety training.</li> <li>Maintain a current and detailed knowledge of cGMP.</li> <li>Seek ways to increase operational efficiency.</li> <li>Participate in special projects as required.</li> <li>Other duties as assigned by the custodial supervisor.</li> <li>Assists with continuous improvement projects within the department</li> </ul>The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills<ul> <li>Completion of Grade 12 from an accredited educational institution preferred combined with minimum 1 year of related experience. </li> <li>Experience in a pharmaceutical manufacturing environment is an asset.</li> <li>Good working knowledge of janitorial functions and the ability to operate powered cleaning equipment.</li> <li>Strong interpersonal and communication skills.</li> <li>Cooperative approach to teamwork with emphasis on successfully completing site goals and providing strong customer service to internal stakeholders.</li> <li>Strong organizational and planning skills with a great attention to detail.</li> </ul> Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Custodial & Grounds Technician

Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position. I. JOB SUMMARY Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. General <ul> <li> Complete training and demonstrate competency on Assistant Manufacturing Associate qualification blocks in accordance with the training progression pathway </li> <li> Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures </li> <li> Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook </li> <li> Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing areas per Standard Operating Procedures </li> <li> Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform real time" review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift </li> <li> Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials </li> </ul> Lean Concepts <ul> <li> Follow standard work guidelines </li> <li> Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts </li> <li> Actively participate in Kanban and 6S programs </li> </ul> Inspection and Packaging <ul> <li> Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification) </li> <li> Independently operate labeling equipment with minimal supervision (Qualification) </li> <li> Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation) </li> <li> Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging) </li> <li> Complete ambient tracking documentation </li> <li> Execute material issuance and confirmation of process steps using specific SAP modules </li> </ul> Building 55 Operations - Prep <ul> <li> Execute material issuance and confirmation of process steps using specific SAP modules </li> <li> Precisely weigh and hydrate media components </li> <li> Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures </li> <li> Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts </li> <li> Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV) </li> <li> Prepare and dispense intermediate materials. </li> </ul> Behavior/Cultural Responsibilities <ul> <li> Standing Shoulder to Shoulder (no matter what): <ul> <li> working collaboratively with others, communicating, and managing conflict effectively </li> </ul> </li> <li> Break Through Thinking: <ul> <li> cultivating innovation and nimble learning </li> </ul> </li> <li> Own It Always: <ul> <li> ensuring accountability, and making good and timely decisions </li> </ul> </li> <li> Compete Where It Counts: <ul> <li> demonstrating courage and focusing on customers </li> </ul> </li> <li> Integrity and Instills Trust: <ul> <li> gaining the confidence and trust of others through honesty, integrity and authenticity </li> </ul> </li> <li> Manages Complexity: <ul> <li> making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem </li> </ul> </li> <li> Plans and Aligns: <ul> <li> plan and prioritize work to meet commitments aligned with organizational goals </li> </ul> </li> <li> Drives Engagement: <ul> <li> creating a climate where people are motivated to do their best to help the organization achieve its objectives </li> </ul> </li> </ul> The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS <ul> <li> HS Diploma </li> <li> 0-1-year experience working in a CGMP environment </li> <li> Knowledge of CGMP and CFR requirements preferred but not required </li> <li> Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware </li> </ul> If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $34,000 to $41,200. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Assistant Manufacturing Associate

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY Responsible for designing, developing, managing, and/or maintaining equipment which is used to monitor and control engineering systems, machinery, and processes. Also responsible for the interface between the hardware and software development for the automation system. Provide professional assistance and technical advice to support ongoing operations/manufacturing investigations through data analysis and team-based problem solving methodologies. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. <ul> <li> Responsible for requirements gathering, design, configuration, integration and implementation of process control solutions for the manufacturing industry including batch software, PLC / DCS systems, HMI packages, SCADA systems, Visual Basic and PC networking technology </li> <li> Background in computer system validation and related practices, including governmental regulations, is preferred. Developing broader skills and applies this knowledge and skills to perform a variety of standard activities </li> <li> Preparation of design packages and specification, functional specifications related to software and hardware RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions </li> <li> Preparation of engineering standards, approval of submittals, and authoring PMs, SOPs, Commissioning Protocols, and conducting training for new equipment installations </li> <li> Author, review, and approve automation system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols) </li> <li> Influence other members of the Project Engineering and SME's on project teams to drive continuous improvement, knowledge transfer, and professional growth of both you and your colleagues </li> <li> Identify areas to drive down project costs through lessons learned and develop specific improvement strategies to realize these savings. </li> <li> Experienced professional with full understanding of work; resolves a wide range of issues in creative ways. </li> <li> Work on problems of increasingly diverse scope; analysis of situation/data requires evaluation of identifiable factors. </li> <li> Demonstrates good judgment in selecting methods and techniques for resolving issues and obtaining solutions. </li> <li> Receives little instruction from supervisors, general instructions on new assignments. </li> <li> Drive the complete execution of assigned projects in manner that drives high engagement from project team members. </li> </ul> The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Required <ul> <li> A minimum of 5 years of experience in a GMP regulated or related environment with some level of computer system validation. </li> <li> BS in Engineering, Science, Project/Program Management, or equivalent experience <ul> <li> EE or Computer Science preferred </li> </ul> </li> <li> Technology/Equipment (DP/DS/Clinical/Commercial/SS/SU) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and reliability for these technologies. </li> <li> Ability to think and act both strategically and tactically </li> <li> Highly effective verbal and written communicator at all levels of the organization </li> <li> Demonstrated ability to effectively prioritize and coordinate activities </li> <li> Proficiency in Microsoft Office applications </li> <li> Strong knowledge of engineering and related practices and preferred knowledge in applicable governmental regulations - ISPE GAMP, EU Annex 11, CFR 210, 211, Part 11 </li> <li> Proven programming experience with either of the following industrial automation systems: Allen-Bradley PLCs or Emerson DeltaV DCS </li> <li> Must have knowledge of process manufacturing field instrumentation, technology, and batch process manufacturing expertise </li> <li> Experience in all phases of the automation project life cycle: Requirements documentation, detailed design generation, implementation, system integration, testing, on-site startup and ongoing system maintenance </li> </ul>U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $95,500 - $115,600. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.

Automation Engineer 2

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. JOB SUMMARY The Director, Medical Affairs will be an integral part of the Global Medical Affairs team. They will be responsible for providing scientific thought leadership and support across the medical affairs efforts in the opioid antidote therapeutic area. This will include supporting strategy in both US and ex-US as aligned medical engagement initiatives. Specific duties include strategy as a subject matter expert, leading Promotion Review Team for medical, coordinating Medical Information needs with our communications team and engaging with external experts as part of medical affairs strategy for publications/IIS/CME. This role will also serve as a training and scientific matter expertise for internal needs within the therapeutic area or brand. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. &bull; Serve as the subject matter expert to support therapeutic area priorities and growth strategies &bull; Lead as the primary Medical Reviewer and Subject Matter Expert (SME) for Promotional Review Committee (PRC) and Medical Review Committee (MRC) &bull; Provides medical review of Promotional and Medical Affairs materials to ensure statements are scientifically accurate, truthful and non-misleading, and that promotional claims are adequately supported, including the appropriateness of references cited &bull; Lead cross-functional teams (including Marketing, Regulatory Affairs, and Legal) to ensure collaborative outcomes on workstreams aligned to scientific strategy &bull; Support/lead content development in collaboration with the Medical Communications team for Medical Information, Training related documents; with ability to submit documents into Veeva Vault as needed &bull; Create, review, and maintain Medical Affairs scientific materials, scientific slide decks, and internal training/directive documents &bull; Lead collaboration with Medical Communications to support Med Inquiries and engage in appropriate scientific exchange &bull; Collaborate with Medical Affairs team members and external vendors/consultants to facilitate the development of content for specific identified goals aligned to strategy &bull; Collaborate with Global Safety & Epidemiology, to provide support for data generation and any potential external communication tools (pubs, presentations) &bull; Provide training to internal business partners as needed on disease state or product The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS &bull; Advanced scientific or clinical/medical degree required (MD, DO, PharmD, PhD) &bull; Experience in leading cross functional teams within a complex matrix &bull; Understanding of US business and Ex US needs to develop comprehensive support plans &bull; 5+ years of working experience within the pharmaceutical industry and 2+ years of professional experience in Medical Affairs is required &bull; Lead promotional/medical review -experience required &bull; Prior experience in digital review systems is required; Veeva Vault and/or Veeva Med Comms is preferred &bull; Prior experience in training/teaching &bull; An established track record of facilitating effective high-quality medical communications &bull; Strong organizational skills &bull; Strong scientific acumen with the ability to translate and effectively communicate complex scientific data for varying audiences. &bull; Strong project management skills with a proven track record to deliver multiple projects in time and excellent quality If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $192,500-$233,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.