Senior Director, Chemistry, Manufacturing & Controls (CMC)
manufacturing › Chemistry, Manufacturing & Controls (CMC) · M6 — M6 — Vice President · Management
Senior leader who directs the CMC strategy, teams, and cross-functional execution for a company's product portfolio.
Median pay · United States · annual
$249,314 USD
▲ +182.2% vs M1 on this ladder
Typical range ()
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6 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
Senior leader who directs the CMC strategy, teams, and cross-functional execution for a company's product portfolio. At the Vice President (M6) level, the role owns a major function or division, enterprise priorities and external factors, and drives division-wide / organization-wide. Leads the leadership of a division.
What this level does
- Serves as functional head of the CMC practice, holding a dual mandate for technical leadership and commercial growth of CMC service offerings
- Defines long-term CMC strategy and corporate policy, leading through senior managers across functions or divisions with long-term effect on company success
- Represents the firm at industry conferences, client meetings, and business development events to build market visibility for CMC services
- Drives global CMC policies and high-stakes regulatory negotiations, negotiating with executives on critical corporate matters
- Knowledge applied
- Sets long-term CMC vision and corporate policy while retaining hands-on scientific/operational credibility as practice head.
- Complexity & problem solving
- Addresses abstract, cross-functional CMC issues, balancing technical leadership with commercial growth of service offerings.
- Collaboration & interaction
- Negotiates with executives and external agencies on critical matters and represents the firm externally to build market visibility.
- Typical experience
- 12–15+ years of deep CMC leadership across departments or divisions.
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
Source · canon-v2 cell + salary-benchmark (model)
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