Senior DCT Lead, Biologics Analytics & CMC
MSD
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Job summary
MSD in Rahway, NJ seeks an Early-Stage DCT Leader to drive integrated CMC programs for pipeline biologics, from candidate selection to early clinical development. You will provide strategic direction for matrix teams and guide analytical control strategies, CQAs, and regulatory interactions.
Ideal candidates have 8+ years of biopharma CMC leadership, strong experience in analytical development and regulatory filings, and a proven track record in cross-functional collaboration and risk
Qualifications
- PhD or MSc/BS with extensive biopharma CMC leadership experience.
- Proven cross-functional leadership across drug substances, analytics and regulatory.
- Strong biologics analytical development and CQAs expertise.
- Experience with regulatory filings (IND/IMPD) authoring and reviews.
- Experience with matrix leadership and risk management.
Responsibilities
- Lead integrated CMC program for pipeline biologics and milestone readiness.
- Operate matrixed CMC teams with clear decision rights and timelines.
- Align CMC interfaces across Drug Substance, Drug Product, Analytical Development, Regulatory, QA, and Supply Chain.
- Identify program risks and develop data-driven contingency plans.
- Define analytical control strategies and CQAs for early-phase programs.
Skills
Education
Tools
Job description
MSD in Rahway, NJ seeks an Early-Stage DCT Leader to drive integrated CMC programs for pipeline biologics, from candidate selection to early clinical development. You will provide strategic direction for matrix teams and guide analytical control strategies, CQAs, and regulatory interactions.
Ideal candidates have 8+ years of biopharma CMC leadership, strong experience in analytical development and regulatory filings, and a proven track record in cross-functional collaboration and risk
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