CMC Supervisor
manufacturing › Chemistry, Manufacturing & Controls (CMC) · M1 — M1 — Manager (Team Lead) · Management
Frontline supervisor overseeing a small team responsible for CMC documentation and manufacturing control activities.
Median pay · United States · annual
$88,342 USD
Typical range ()
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Track
Management
Family rungs priced
M1 · M2 · M3 · M4 · M5 · M6
Coordinates
3 / 4 spaces
pay@2 · 2026-07
What this role is
Frontline supervisor overseeing a small team responsible for CMC documentation and manufacturing control activities. At the Manager (Team Lead) (M1) level, the role owns a single team, day-to-day delivery and people issues, and drives team output and health. Direct people management of one team.
What this level does
- Supervises a unit of associate scientists, CMC analysts, and QA associates performing data collection, testing, and documentation, ensuring daily lab throughput and record accuracy
- Oversees core lab chemistry execution — synthesis and purification of drug substances — assigning bench work and reviewing results against established protocols
- Ensures the team's CMC documentation supporting IND filings is completed accurately and on schedule under established practices
- Coordinates day-to-day with regulatory affairs, quality assurance, and manufacturing peers to keep quality-control and manufacturing-support tasks moving
- Knowledge applied
- Functional expert in core lab chemistry (synthesis, purification, analytical testing) applying established CMC and GMP practices to supervise a unit's daily execution.
- Complexity & problem solving
- Limited scope; resolves routine testing, documentation, and scheduling issues using established procedures and escalates deviations.
- Collaboration & interaction
- Daily interactions with unit staff and peer scientists in QA, RA, and manufacturing to keep lab and documentation work on track.
- Typical experience
- Functional CMC expertise with some leadership exposure; typically a senior scientist stepping into first-line 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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