Johnson & Johnson is recruiting for a Principal Scientist, CAR-T Analytical Scientific Integrator - Advanced Therapies located in Malvern, PA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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The Principal Scientist, CAR-T Analytical Scientific Integrator will provide analytical, technical and strategic leadership to a matrixed team, in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s). This role is also responsible for the output and quality for technical reports and regulatory documentation through the writing of technical analytical content for regulatory submission and provide strategy to meet regional customer requirements in the U.S., EMEA and Asia Pac.
Key Responsibilities:
- Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the Analytical Development (AD) sub-functions.
- Represent AD on the CMC team and accountable for all AD project deliverables.
- Coordinate the execution of cross-site, cross-functional analytical deliverables, for method development, process scale-up and tech transfer, through commercialization.
- Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and heightened concerns.
- Collaborate with various partners outside of Discovery, Product Development & Supply, including Commercial Manufacturing, Regulatory, Quality, Discovery and external partners.
- Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.
- Lead the analytical review of programs at governance meetings with support from subject matter experts.
- Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
- Effectively communicate project status/overview, resources, budget, and issues to senior management.
Qualifications
Education:
- PhD in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development OR a Master's degree with 5+ years of experience in biopharmaceutical development OR a Bachelor's degree with 8+ years of relevant experience is required.
Experience and Skills:
Required:
- 2+ years of experience on cross-functional CMC teams or analytical sub-teams with the ability to lead and implement complex plans/deliverables in a matrix environment is required.
- Knowledge of analytical development, experience in cell therapy & viral vector is required.
- Ability work collaboratively in a complex environment is required.
- Excellent oral and written communication skills are required.
- Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required.
Preferred:
- Strong negotiation skills with a proven ability to complete and get results in a complex environment is preferred.
- Knowledge of potency assays and/or cellular immunology is preferred.
- Knowledge of basic immunology techniques is required, including mammalian cell culture, FACS, immunofluorescence, ELISA, and qPCR is preferred.
- Knowledge of the development and registration of cell therapy products is preferred.
- Ability to make timely decisions and operate effectively in times of ambiguity is preferred.
- Strong analytical problem solving, planning and organizational skills are highly preferred.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.