Early-Stage Biologics DCT Lead
Merck
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Descrizione del lavoro
Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead Early-Stage Development and Commercialization Teams, directing integrated CMC strategies for pipeline biologics from candidate selection through early clinical development.
The role emphasizes cross-functional leadership across Drug Substance, Drug Product, Analytical Development, Regulatory, and Quality, with a strong emphasis on risk management, data-driven decision making, and readiness for regulatory filing and launch.
Competenze
- Ph.D. with 8+ years in biopharmaceutical industry; or
- M.S. with 10+ years in biopharma; or
- B.S. with 14+ years in biopharma.
Mansioni
- Lead Early-Stage Development and Commercialization Team (DCT) with accountable integrated CMC strategy.
- Drive cross-functional alignment across Drug Substance, Drug Product, Analytical Development, Regulatory, QA, and Supply.
- Frame program decisions, manage risks, escalate to leadership as needed.
- Mentor scientists to meet milestones and regulatory documentation.
- Support regulatory submissions and launch readiness activities.
Conoscenze
Formazione
Descrizione del lavoro
Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead Early-Stage Development and Commercialization Teams, directing integrated CMC strategies for pipeline biologics from candidate selection through early clinical development.
The role emphasizes cross-functional leadership across Drug Substance, Drug Product, Analytical Development, Regulatory, and Quality, with a strong emphasis on risk management, data-driven decision making, and readiness for regulatory filing and launch.
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