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CAR-T Scientist, Analytical Development Manager
Requisition ID: 3020180209
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Scientist, 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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
We are seeking to hire a highly energetic and collaborative scientist to manage and lead our chimeric antigen receptor T cell (CAR-T) analytical development team.
The individual will be responsible for:
- Supporting CAR-T analytical development activities
- Supervising a team of analytical scientists in a GMP QC 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 5 years of industry experience OR a PhD with relevant industry experience is required
- Experience supervising direct reports in 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
Experience with the development of cell and/or gene therapy products is preferred
QC clinical release testing experience is preferred
Janssen Research & Development, LLC. (6084)