Johnson & Johnson Careers
Principal Scientist, CAR-T Drug Product Development
Requisition ID: 0314190326
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, located in Malvern, PA.
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 Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
- Define strategy per program/project/technology timelines.
Lead product formulation design/selection including characterization studies relevant to the stage of development to manufacture robust CAR T products. Studies include, but are not limited to, stability, cryopreservation, formulation composition selection/optimization and robustness.
Evaluate & implement new technologies for engineered T cell to improve formulation and process.
Author and review documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Design experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters.
Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, project issues and deviations.
Deliver an improved focus on the scientific rigor within DPD, ensuring consistent scientific excellence and scientific quality standards are met.
PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with 7 years of experience OR a Masters in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 10 years of experience is required
- Breadth of knowledge across cell therapy technologies, cell therapy manufacturing, cell characterization method development for T-cells or other primary cultures or stem cells is required
Strong communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required
The candidate should be able to use emerging developments in relevant scientific fields to generate new research ideas and initiatives.
Working knowledge of flow cytometry, ELISAs, cell-based assays, and compendial methods for cell and gene therapy is preferred
Understanding of process development/qualification and GMP manufacturing of cell therapy and use of closed-systems, single-use or disposable technology for sterile and aseptic processing applications is preferred
Drug Product Development experience that spans early through late with demonstrated project leadership is preferred
- Experience with authoring and reviewing regulatory filings is preferred
Expertise in cell therapy product development required with experience in biologics/gene therapy preferred.
This position will be based in East Coast, US and may require up to 15% international and domestic travel
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)