Senior Scientist, CAR-T Analytical Scientific Integrator
- Malvern, PA
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, CAR-T Analytical Scientific Integrator . The position will be 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Janssen Research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
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).
The Senior Scientist, CAR-T Analytical Scientific Integrator will have responsibilities including but 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 M.S. with 10 years of experience in biopharmaceutical development
- At least 2 years of experience on cross-functional CMC teams
- Ability work collaboratively in a complex, matrix environment
- Excellent oral and written communication skills
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment
- Strong negotiation skills with a proven ability to execute and get results in a matrix environment
- In-depth large molecule, protein-based vaccine, viral vector and/or cell therapy analytical development experience
- Knowledge of antigenicity assays, potency assays and/or cellular immunology
- Knowledge of basic immunology techniques is required, including mammalian cell culture, FACS, immunofluorescence, ELISA, SPR, and PCR
- Experience with the development and registration of vaccine, cell and/or gene therapy products; and development of oncolytic virus gene therapies is a plus
- Ability to make timely decisions and operate effectively in times of ambiguity
- Strong analytical problem solving, planning and organizational skills
- Ability to filter information and escalate issues as appropriate
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)
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