M1
jf_chemistry_manufacturing_controls_cmc::M1
CMC Supervisor

CMC Supervisor

manufacturingChemistry, 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 ()

$64,892$120,264

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Track

Management

11-0000

manufacturing

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.

Model-authored from 13 retrieved sources, then adversarially reviewed by an independent judge panel and held to a minimum-evidence floor before publication. Distinct from corpus-extracted content, which is labelled as such.

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As of · 2026-07-30

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