Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist- Analytical Development -Cell & Gene Therapy, Vaccines. The position will be located in Malvern, PA
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are seeking to hire a highly energetic and collaborative, Scientist to join our Cell & Gene Therapy, Vaccines analytical development team.
- Lead development, qualification, validation and transfer of new and existing analytical methods.
- Drive efficiencies; incorporate innovation into existing methods.
- Author protocols and reports, as well as perform and coordinate testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups.
- Author analytical sections of regulatory submissions that support regulatory filings including INDs and BLAs.
- Provide technical support to QC laboratories, and assist 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.
- Shift work may be required.
- Ph.D. in biology, immunology or other relevant scientific field with at least 2 years of relevant experience or Master’s degree, with at least 6-7 years of relevant experience or a Bachelor's degree, with at least 9-10 years of relevant experience.
- Experience in development of cell-based assays, and knowledge of cellular immunology is required.
- Knowledge of basic immunology techniques is required, such as mammalian cell culture, ELISA, PCR.
- Hands-on experience with CAR-T or other cell and gene therapy products highly preferred.
- Knowledge of analytical method development of potency assays, in-vitro tumor killing assays, binding assays and/or residual impurity assays is preferred.
- Experience working in a cGMP environment is preferred.
- Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is helpful.
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)