CMC Senior Supervisor
manufacturing › Chemistry, Manufacturing & Controls (CMC) · M2 — M2 — Manager II · Management
Leads a team of CMC specialists, overseeing daily execution of manufacturing control and compliance activities.
Median pay · United States · annual
$113,967 USD
▲ +29% vs M1 on this ladder
Typical range ()
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2 of 8
Track
Management
Family rungs priced
M1 · M2 · M3 · M4 · M5 · M6
Coordinates
3 / 4 spaces
pay@2 · 2026-07
What this role is
Leads a team of CMC specialists, overseeing daily execution of manufacturing control and compliance activities. At the Manager II (M2) level, the role owns an established team or sub-function, cross-project coordination and priorities, and drives group delivery and development. Manages a team; sometimes manages leads.
What this level does
- Leads a skilled team of scientists and specialists providing technical support for technology transfer, CMC documentation, and manufacturing readiness
- Owns tactical outcomes for CMC regulatory activities on assigned investigational products — IND/IMPD sections, annual reports, and responses to health authority questions
- Applies judgment within known factors to resolve OOS/OOT and stability issues escalated by the unit, deciding when to invoke investigations
- Coordinates cross-functionally to prepare CMC regulatory content (INDs/CTAs and amendments), balancing team workload against submission timelines
- Knowledge applied
- Applies deeper CMC regulatory and technology-transfer knowledge to lead skilled ICs preparing submission content and manufacturing-readiness support.
- Complexity & problem solving
- Exercises judgment within known factors — deciding investigation triggers for OOS/OOT/stability and sequencing submission tasks under deadlines.
- Collaboration & interaction
- Cross-functional cooperation with RA, QA, and manufacturing to align documentation and technology-transfer deliverables.
- Typical experience
- 2–5 years in team leadership or specialist CMC/regulatory roles with limited management supervision.
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
Edition · canon-v2@2.1.0-complete
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