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Associate Director, Analytical Scientific Integrator - Biopharmaceuticals
Requisition ID: 9500180509
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 biopharmaceutical programs in clinical development for non-monoclonal modalities, such as vaccines, CAR-T therapies and oncolytic virus gene therapies. The individual would provide analytical technical and strategic leadership, in addition to representing LMAD on the CMC team(s). Responsibilities include but are not limited to the following:
Lead a cross-functional scientific team consisting of members from each of the analytical sub-functions
Lead the development and execution of analytical 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
Ensure the submission of complete, consistent, comprehensive, high quality dossiers
Effectively communicate project status, resources, budget and issues to senior management
Represent analytical 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
Ph.D. in Biochemistry, immunology, virology, biological science, or related discipline with 8 years of experience in biopharmaceutical development OR a M.S. with 10 years of experience in biopharmaceutical development is required
At least 2 years of experience on cross-functional CMC teams is required
In-depth large molecule, protein-based vaccine, viral vector and/or cell therapy analytical development experience is preferred
Knowledge of antigenicity assays, potency assays and/or cellular immunology is preferred
Knowledge of basic immunology techniques (ie: mammalian cell culture, FACS, immunofluorescence, ELISA, SPR, and PCR) is preferred
Experience with the development and registration of vaccine, cell and/or gene therapy products; and development of oncolytic virus gene therapies are preferred
Janssen Research & Development, LLC. (6084)