Senior Associate Scientist, Process Analytical Sciences - Cell & Gene Therapy, Vaccines
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Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, Process Analytical Sciences - Cell & Gene Therapy, Vaccines located in Malvern, PA or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
We are seeking to hire a highly energetic and collaborative, Senior Associate Scientist to join our CAR-T Process Analytical Support (PAS) team.
The individual will be responsible for:
• Supporting CAR-T product development, serving as an in-process analytical expert
• Coordinating and performing sample testing to support manufacturing process development, process validations, and manufacturing investigations
• Ensure the maintenance of laboratory notebooks and detailed records in compliance with applicable GxP, safety, and environmental requirements
• Perform instrument IO/OQ/PQ, review logbooks and maintain general laboratory operations
• Routinely support QA and regulatory agencies during audits
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance
• Shift work may be required as well as travel between sites.
• Bachelor's degree in biology, immunology or other relevant scientific field, with at least 3-4 years of relevant experience OR a Master's degree with 1-2 years of relevant experience is required.
• Hands-on experience with CAR-T or other cell and gene therapy products is preferred.
• Highly proficient in multi-color flow cytometry or PCR is required.
• Extensive experience in cell-based bioassay is preferred.
• Experience with routine analytical sample testing for a variety of cell-based bioassays, binding assays and/or residual impurity assays is required
• Experience developing procedures and transferring of processes in a cGMP facility or environment is preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)