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Associate Director - Scientific Integrator, Large Molecule Analytical Development
Requisition ID: 9500170505
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, 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.
The Large Molecule Analytical Development (LMAD) group is seeking a Scientific Integrator (SI) who will lead the analytical team for large molecule projects (biopharmaceutical and/or vaccine) in clinical development, provide technical and strategic leadership, and represent LMAD on the CMC teams. Responsibilities include but are not limited to the following:
Lead a cross-functional scientific team consisting of members from each of the LMAD sub-functions
Lead the development and execution of analytical strategy for early phase through commercial launch
Accountable to the CMC team for all LMAD deliverables
Responsible for leading the analytical review of each program at governance meetings with support from subject matter experts
Ensure the submission of complete, consistent, comprehensive, high quality dossiers.
Effectively communicate project status, resources, budget and issues to senior management.
Represent LMAD at health authority inspections and meetings with health authorities.
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 PDMS, including Commercial Manufacturing, Regulatory, Quality, Discovery, and external partners
Additional responsibilities include method transfers to commercial sites, analytical control strategy, justification of specifications, and criticality analysis.
BS in Biochemistry, Biological Sciences, Bioanalytical Chemistry, or related discipline with at least 15 years of experience in biopharmaceutical development OR a MS in Biochemistry, Biological Sciences, Bioanalytical Chemistry, or related discipline with at least 10 years of experience in biopharmaceutical development OR a Ph.D. in Biochemistry, Biological Sciences, Bioanalytical Chemistry, or related discipline with at least 8 years of experience in biopharmaceutical development is required
- At least 2 years of experience on cross-functional CMC teams is required
- Ability work collaboratively in a complex, matrix environment
- Strong negotiation skills with a proven ability to execute and get results in a matrix environment
- In-depth large molecule and vaccine Analytical Development is required
Previous leadership experience (coaching, mentoring, leading projects) is preferred
Experience in biopharmaceuticals, microbiome, vaccines, fusion proteins, cell gene therapy and/or protein conjugates is preferred
Janssen Research & Development, LLC. (6084)