CMC Principal - Drug Substance

Senior Recruitment Consultant:
Supply Chain & Procurement at Discover International

CMC Drug Substance Principle

Switzerland - 3 Days onsite / 2 Days from home

We’re partnering with an innovative biopharma company seeking a Drug Substance Principal SME to provide technical leadership across development, tech transfer, and commercial manufacturing within a global CDMO network.

This role owns the technical strategy and execution of Drug Substance processes from development through commercialization.

• Lead end-to-end Drug Substance tech transfers (site to site, development to commercial) with accountability for timelines, risks, and budgets
• Define and drive DS manufacturing strategy (upstream & downstream) to ensure robust, scalable, and cost-effective processes
• Provide hands‑on technical oversight of process development, scale‑up, validation, and ongoing manufacturing at CDMOs
• Act as the Drug Substance SME, supporting troubleshooting, deviations, CAPAs, and change controls
• Lead CDMO technical due diligence, onboarding, and governance
• Support comparability, lifecycle changes, and continuous improvement initiatives
• Provide technical input to regulatory submissions and support inspections and audits

• 7+ years in biopharma working with biologic drug substances
• Strong experience in MSAT, process development, tech transfer, or manufacturing
• Proven work with CMOs/CDMOs and commercial production environments
• Solid understanding of cGMP and regulatory requirements
• Degree in Biotechnology, Chemistry, Biochemistry, Pharmacy, or related field
• Comfortable in a global, matrix, hands‑on environment
• Willing to travel internationally

• Mid‑Senior level

• Full‑time

• Manufacturing
• Pharmaceutical Manufacturing and Biotechnology Research

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