Johnson & Johnson Careers
CAR-T Senior Scientist, Analytical Process Support Manager
Requisition ID: 2586180921
- Supporting cell and gene therapy analytical development activities
- Supervising a team of analytical scientists in a GMP laboratory environment
- Perform in-process and release testing, following appropriate SOPs and work procedures.
- Support 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
- Interface with QA and regulatory agencies during audits
- Accurate capture of data in a timely manner and entry into appropriate systems (e.g. LIMS), including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected and the successful candidate will ensure data integrity and protocol compliance
- Master's degree with at least 10 years of industry experience, OR a PhD with at least 5 years of industry experience is required
- Line management experience, supervising direct reports is required
- CMC experience is required
- Extensive experience with human immune cell culture, related functional assays, and a comprehensive knowledge of cellular immunology is required.
- Knowledge of basic immunology techniques is required, including mammalian cell culture, FACS, immunofluorescence, ELISA, PCR, cytokine and chemokine detection
- Experience with analytical method development for a variety of cell-based bioassays, binding assays and/or residual impurity assays is preferred
- Analytical experience with viral vector development and testing is preferred
- QC clinical release testing experience 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)