Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Early Development Analytical Scientific Integrator (1 of 2). The position is located in Malvern, PA (3 days in the office).
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 Scientific Affairs, LLC is part of the Janssen Pharmaceutical Companies.
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The Discovery, Product Development, and Supply (DPDS), Analytical Development (AD) group is seeking a Senior Scientist for an Early Development Analytical Scientific Integrator role. The candidate will lead a cross-functional analytical teams for biopharmaceutical programs in early stage clinical development. This individual will provide technical and strategic leadership to analytical teams and represent BioTD AD on the Chemistry, Manufacturing, and Controls (CMC) team(s).
Principal Responsibilities
- Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
- Represent AD on the CMC team and accountable for all AD project deliverables.
- 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.
- Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.
- Interact with and influence various stakeholders outside of DPDS including Manufacturing, Regulatory, Quality, Discovery, and external partners.
Qualifications
- A minimum of a Master's degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 8 years of experience in biopharmaceutical development is required. A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 3 years of experience in biopharmaceutical development is preferred.
- A minimum of 2 years of experience on cross-functional analytical sub-teams and/or CMC teams with the ability to lead and execute complex plans/deliverables in a matrix environment is required.
- Working knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.
- Experience authoring and reviewing CMC sections of clinical trial applications (INDs/IMPDs) and addressing health authority questions is required.
- Must have strong leadership, communication (oral and written), interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment.
- This position is to be based in Malvern, PA at least 3 days a week and may require up to 10% travel.
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.