Senior Scientist - Analytical Development - Gene Therapy
- Malvern, PA
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Analytical Development - Gene Therapy, located in Malvern, 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.
The Senior Scientist, Analytical Development - Virology will be responsible for development of assays for viral products, such as infectivity and titer assays, to be used in support of clinical development.
• Responsibility for method development, qualification, validation and transfer activities
• Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
• Writing analytical sections of regulatory submissions is expected and the successful candidate will support regulatory filings including INDs and BLAs
• Providing technical support to QC laboratories, and assisting in investigations
• Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected
• Ph.D. in Biochemistry, immunology, virology, biological science, or related discipline with at least 3 years of experience in biopharmaceutical development, or M.S. with at least 8 years of experience in biopharmaceutical development
• Knowledge of virology and related analytical methodologies
• Experience with plaque assays, titer assays, flow cytometry, PCR/qPCR, and ELISA
• Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
• Excellent oral and written communication skills
• Experience handling multiple virus families and/or multiple viral vectors
• Experience with cell and gene therapy and/or vaccines
• People management experience
• Strong analytical problem solving, planning and organizational skills
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.
Janssen Research & Development, LLC (6084)
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