Johnson & Johnson Careers
Director, Bioassay Method Development
Requisition ID: 1969190107
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, 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.
- Lead the Bioassay Team of >60 scientists to deliver on the development of Bioassays from Phase I clinical through commercial launch. This includes development of methods for clinical and commercial release testing, support for process development, automation of assays, and Regulatory filings.
- Provide strategic and scientific guidance in all Bioassay CMC technical areas (cell-based potency assays, residual host cell protein and DNA assays, cell and gene therapy product characterization assays, flow-cytometry, and BIACore).
- Responsible for method development, validation, and transfers of Bioassay methods and lifecycle technical support
- Collaborate cross-functionally to establish mechanism of action and structure-function relationships.
- Drive innovation and continuous improvements in the Bioassay group.
- Guide teams in the preparation of regulatory submissions for IND and BLA globally.
- Coach and mentor staff on their projects and their careers.
- Ph.D. in Biochemistry, Biology, Immunology, Biological Chemistry, or related discipline is required
- At least 12 years of relevant technical and leadership experience in biopharmaceutical development and licensure is required
- Primary in-depth experience in protein pharmaceutical development is needed including large molecule analytics and experience in authoring relevant portions of IND and BLA for Bioassays
- Experience in cell-based bioassay, flow-cytometry, immunoassay, & qPCR is preferred
- Experience in method validation and transfers to meet ICH guidelines under GMP environment is required
- Experience in supervision of method transfer in a current GMP environment is preferred
- Excellent oral and written communication skills is a must
- Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Janssen Research & Development, LLC. (6084)