Senior Scientist, Molecular and Viral Safety (Onsite)

The Molecular & Viral Safety group within Cell Based Sciences, Analytical R&D is seeking applicants for a Senior Scientist position located at our West Point, PA research facility. The successful candidates will contribute to delivering analytical solutions that enable and accelerate process and product development to ensure safety and quality of our products. Key deliverables will include technical review, scientific oversight and operational delivery of viral and biosafety testing for cell substrates and virus stocks used for GMP manufacturing.

The successful candidates will be able to collaborate in a dynamic, integrated, and multidisciplinary team environment working across both Vaccine and Biological modalities. An expansive range of analytical tools (e.g. microbiology, in vivo, molecular biology, Sanger and next generation sequencing, etc.) are leveraged and new technologies are developed to ensure that our vaccine and biologic products are free of adventitious agents.

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, transfer 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.

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.; or a master’s degree with a minimum of 5 years’ experience; or bachelor’s degree with a minimum of 8 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 with 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:

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.

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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.

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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Employee Status: Regular

Relocation:Domestic

VISA Sponsorship:Yes

Travel Requirements:10%

Flexible Work Arrangements:Not Applicable

Shift:Not Indicated

Valid Driving License:No

Hazardous Material(s):NA

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