Job Abstract

Job Description

Job Description:

The Molecular & Viral Safety group within Cell Based Sciences, Analytical R&D is seeking applicants for an Associate Principal Scientist position located at our West Point (PA) or Rahway (NJ), research facility. The teams responsibility is to deliver analytical solutions that enable and accelerate process and product development to ensure safety and quality of our products.  The successful candidates will be able to collaborate in a dynamic, integrated, and multidisciplinary team environment working across both Vaccine and Biological modalities.

The successful candidate will be a critical point of contact for all Cell Banking and Virus Seed analytical activities.   Key deliverables will include technical review and authoring, scientific oversight and operational delivery of viral and biosafety testing for cell banks and virus stocks used for GMP manufacturing.  An expansive range of analytical tools (e.g. for cell culturing, identity, microbiology, adventitious viral agents and molecular biology testing )are leveraged and new technologies (like Next Generation Sequencing) are developed and implemented to ensure that our vaccine and biologic products are free of adventitious agents according to the revised ICH guideline.

Responsibilities include:

• Design and develop analytical strategies for cell banks, viral stocks and UPB/VHF with line of site from pre-clinical through to the commercialization across biologics and vaccine modalities.

• Build and maintain deep technical expertise in area of cell banking and/or adventitious virus testing.

• Author methods, technical protocols and reports and technical assessments according to current regulatory requirements.

• Demonstrate effective multitasking, prioritization and problem-solving skills in the operational oversight characterization and release testing of cell banks and virus seeds of planning and execution of experiments.

• Support the implementation of new sequencing-based technologies for adventitious agent testing.

• Contribute to technical reports and sections of regulatory filing documents.

• Contribute to solving complex problems and technical advances in the field.

• Effectively collaborate in a fast-paced, integrated, multidisciplinary team environment.

Education Minimum Requirement:

• A Ph.D. with a minimum of 4 years’ experience; or a master’s degree with a minimum of 8 years’ experience; or bachelor’s degree with a minimum of 12 years’ experience in virology, microbiology, molecular biology, biological sciences, or related discipline in the biopharmaceutical industry.

Required Experience and Skills:

• Strong background and direct experience within the fields of cell banking, adventitious agent testing, and/or analytical assay development.

• A strong background in a variety of virology, molecular biology, and microbiology techniques to understand and solve diverse scientific questions.

• ?Demonstrated scientific ability through publications in peer reviewed journals and presentations in scientific conferences.

• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.

• Ability to deliver complex objectives under strict timelines in a rapidly changing environment.

• Ability to work in a diverse, cross-functional team environment.

Preferred Experience and Skills:

• Industrial experience in cell banking activities, including process development and adventitious agent testing

• Working knowledge of regulatory and industry guidelines in the area of biosafety testing, including compendial requirements, CFR and ICH requirements, and WHO/EMA/FDA regulations.

• Familiarity with electronic laboratory notebook applications and good documentation practices.

• Prior work in a biopharmaceutical industry and knowledge of cGMP practices

• Prior background in biologics and/or vaccine GMP manufacturing or analytics.

#AR&D

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

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.

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