Scientist, CAR-T Analytical Development-Cell & Gene Therapy, Vaccines
- Malvern, PA
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for aScientist, CAR-T Analytical Development-Cell & Gene Therapy, Vaccines . Theposition 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 CAR-T analytical development team.
Key responsibilities include but are not limited to:
- Supporting CAR-T product development, serving as an analytical technical expert for multi-color flow cytometry
- Leading methods development, qualification, validation and transfer activities, writing protocols, reports, and performing and coordinating testing to support manufacturing process development, process validations, and manufacturing investigations
- Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner
- Perform instrument IO/OQ/PQ, review logbooks and maintain general laboratory operations
- Interface with Quality Assurance (QA) and regulatory agencies during audits
- Accurately capturing data in a timely manner, ensuring data integrity and protocol compliance
- Shift work may be required
- Master's degree, with at least 6-7 years of relevant experience is required
- Ph.D. with in biology, immunology or other relevant scientific field with at least 2 years of relevant experience is preferred
- Highly proficient with basic immunology techniques is required
- Extensive experience in multi-color flow cytometry is required
- Knowledge of basic immunology techniques including mammalian cell culture, ELISA, SPR, and PCR is required
- Hands-on experience with CAR-T or other cell and gene therapy products is highly preferred
- CMC experience is preferred
- Experience with analytical method development for a variety of cell-based bioassays, binding assays and/or residual impurity assays is preferred
- Experience working in a cGMP environment is preferred
- Knowledge of potency assays and/or cellular immunology 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.
Janssen Research & Development, LLC (6084)
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