Johnson & Johnson Careers
Associate Director, Late Development Analytical Scientific Integrator
Requisition ID: 1841190104
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Associate 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 a cross-functional scientific team consisting of members from each of the AD sub-functions
- Lead the execution of the analytical control strategy
- Be accountable to the CMC team for all analytical deliverables
- Responsible for leading the analytical review of each program at governance meetings with support from subject matter experts
- Effectively communicate project status, resources, budget and issues to senior management
- Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and escalation of issues
- Interact with various stakeholders outside of Discovery Product Development and Supply (DPDS), including Commercial Manufacturing, Regulatory, Quality, Discovery, and external partners
- Accountable for complete, consistent, comprehensive, and high quality regulatory documents
- Additional responsibilities include method transfers to commercial sites, justification of specifications, and criticality analysis
- Ph. D. in Analytical Chemistry, Biochemistry, immunology or related discipline with 8 years of industry experience in biopharmaceutical development OR a M. S. with 15 years of experience in biopharmaceutical development is required
- At least 3 years of experience leading analytical subteams is required
- Ability to work collaboratively in a complex, matrix environment is required
- Strong communication and negotiation skills are required
- A proven ability to execute complex plans in a matrix environment is preferred
- In-depth knowledge of biotherapeutic development and analytical strategy is required
- Knowledge of protein characterization, separation and/or bioassay testing is preferred
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Janssen Research & Development, LLC. (6084)