Senior Manager, Chemistry, Manufacturing & Controls
manufacturing › Chemistry, Manufacturing & Controls (CMC) · M4 — M4 — Director · Management
Leads a team responsible for CMC strategy, documentation, and regulatory compliance across manufacturing processes for one or more pharmaceutical products.
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What this role is
Leads a team responsible for CMC strategy, documentation, and regulatory compliance across manufacturing processes for one or more pharmaceutical products. At the Director (M4) level, the role owns a function or department, strategic priorities and cross-functional alignment, and drives function-level results. Leads managers; sets direction for the function.
What this level does
- Oversees multiple CMC sections or a critical function spanning process development, technology transfer, and regulatory strategy across investigational and commercial products
- Sets CMC strategic policies aligned to business objectives, where lapses could jeopardize submission timelines or commercial supply
- Represents RA CMC on product development and life-cycle management teams, negotiating and influencing peers in RA, R&D, and Operations
- Engages senior leaders on functional CMC strategy for pivotal Phase 2b–3 programs and BLA/NDA readiness
- Knowledge applied
- Applies strategic CMC policy knowledge across multiple sections spanning development, technology transfer, and regulatory strategy for pivotal and commercial products.
- Complexity & problem solving
- Resolves strategic issues aligned to business objectives where errors could jeopardize submissions or commercial supply.
- Collaboration & interaction
- Engages senior leaders and negotiates with peers across RA, R&D, and Operations on functional CMC strategy.
- Typical experience
- 8–10+ years with complex, multi-team CMC and life-cycle-management leadership.
Skills at this level
- Core laboratory chemistry
- — Directs synthesis and purification of drug substances and applies organic chemistry and chemical-safety knowledge to govern bench execution and troubleshooting.
- CMC regulatory strategy
- — Develops and manages content strategy for CMC submissions — INDs/CTAs and amendments, marketing applications, and supplements/variations — to enable first-pass health-authority approvals.
- Technology transfer and manufacturing scale-up
- — Leads transfer of drug substance and drug product processes from development into scaled manufacturing, ensuring readiness across upstream and downstream operations.
- Statistical and trend analysis
- — Uses statistical and trend analysis of process, stability, and analytical data to resolve OOS, OOT, stability, and manufacturing issues.
- Health authority interaction
- — Plans and manages regulatory agency interactions — responding to health authority questions and negotiating CMC positions during submission review.
- Global regulatory strategy
- — Manages global CMC regulatory strategy, agency negotiations, and corporate policy at senior and executive levels.
- Cross-functional collaboration
- — Works across regulatory affairs, quality assurance, and manufacturing to align CMC deliverables and ensure product integrity.
- Full development lifecycle CMC input
- — Provides strategic CMC guidance from early development through Phase 2b–3 pivotal studies, BLA/NDA submissions, and post-approval lifecycle management.
- CMC practice development and business growth
- — Builds the CMC service offering through business development, team building, and market-visibility activities at industry and client events.
- Budget and resource ownership
- — Owns CMC departmental budgets and vendor/resource allocation, shifting toward strategic vendor selection as scope grows.
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As of · 2026-07-30
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Source · canon-v2 cell + salary-benchmark (model)
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