Johnson & Johnson Careers
Senior Associate Scientist, Late Stage Process Development, CAR-T
Spring House, Pennsylvania; Raritan, New Jersey
Requisition ID: 2413190903
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Associate Scientist, Late Stage Process Development, CAR-T to be located in Spring House, PA (strong preference) and will consider Raritan, NJ.
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 BioTherapeutics Development (BTD) is seeking a highly motivated and collaborative Senior Associate Scientist with proven expertise in late stage process development, and/or CAR-T therapy to join our CAR-T Process Development team
Key Responsibilities: You will be supporting the late stage development of a CAR-T manufacturing process.
•Provide technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed.
•Work in a cross-function team analyze manufacturing data, trending key process parameters and working to establish commercial manufacturing control strategy.
•Support manufacturing team in troubleshooting problems as required and provide primary technical support.
•Write and review protocols and technical reports in support of process validation.
•Be familiar with the CMC drug development processes and responsible for authoring regulatory granules for IND/BLA submissions.
•Comfortable with electronic document management systems and authoring tools.
•Bachelor’s degree is required preferably within Engineering, Bio-Engineering, Computer Science, Biology, Immunology, Cell Biology or similar scientific discipline WITH a minimum of 4 years of related industry experience OR Master’s Degree in an appropriate scientific discipline with a minimum of 2 years of related industry experience.
•Experience with mammalian cell culture
•Working knowledge of GLP and GMP requirements
•Excellent Technical Writing Skills required
•Late Stage Process Development experience
•Process control strategy, technology transfer and/or process validation experience
•Experience with Authoring Regulatory Filings
•Prior experience working with Risk Analysis and Risk Management
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.
United States-Pennsylvania-Spring House-
United States-New Jersey-Raritan
Janssen Research & Development, LLC (6084)