CMC Chemist
manufacturing › Chemistry, Manufacturing & Controls (CMC) · P2 — P2 — Developing Professional · Individual contributor
An individual contributor who supports chemistry, manufacturing, and controls activities under routine guidance while building core technical competence.
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Track
Individual contributor
Family rungs priced
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Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
An individual contributor who supports chemistry, manufacturing, and controls activities under routine guidance while building core technical competence. At the Developing Professional (P2) level, the role owns defined deliverables / small features, applies established patterns, and drives own and immediate-team deliverables. May guide interns.
What this level does
- Execute day-to-day small molecule chemistry — route and process development, optimization and cGMP manufacturing — in support of early-phase clinical API production under general instruction
- Collect and analyze CMC data using statistical and trend analyses to help resolve OOS, OOT, stability and manufacturing issues within a defined program
- Provide technical support for technology transfer, CMC documentation and manufacturing readiness on assigned deliverables
- Prepare and assemble sections of technical documentation for annual reports and the CMC portions of IND submissions, reviewing batch records and stability reports for completeness
- Work closely with regulatory affairs, quality assurance and manufacturing to ensure product integrity throughout the drug development process
- Knowledge applied
- Applies developing chemistry/process expertise and statistical/trend techniques to conventional CMC tasks in familiar contexts — bench chemistry, tech-transfer support and IND-section assembly.
- Complexity & problem solving
- Exercises judgment on moderately defined problems, contributing to OOS/OOT/stability investigations under general instruction.
- Collaboration & interaction
- Builds productive working relationships with regulatory, QA and manufacturing colleagues on assigned deliverables; may guide a junior associate.
- Typical experience
- 2+ years with a BA/BS, or MS/PhD with limited experience.
Skills at this level
- Synthetic organic / process chemistry
- — Develops and optimizes synthetic routes and manufacturing processes for drug substance, taking API process development through to cGMP drug-substance manufacturing for clinical supply.
- Statistical and trend analysis
- — Applies statistical and trend-analysis methods to CMC datasets to detect and resolve out-of-specification (OOS), out-of-trend (OOT), stability and manufacturing anomalies.
- CTD authoring and submission assembly
- — Builds and formats Common Technical Document (CTD) modules and assembles the CMC sections of IND, IMPD, NDA, sNDA, BLA and MAA submissions to meet the requirements of one or more health authorities.
- cGMP batch and quality documentation review
- — Reviews batch records, Certificates of Analysis, validation, stability, deviation and CAPA reports to confirm they support product integrity and regulatory adequacy.
- Technology transfer
- — Provides technical support to transfer analytical methods and manufacturing processes between sites or scales, ensuring manufacturing readiness for clinical API production.
- CMC regulatory strategy
- — Plans and defends the CMC control strategy across programs, managing post-approval supplements, annual reports, registration renewals and the sequence of filings for a new chemical entity.
- Health authority interaction
- — Serves as point of contact for regulatory agencies, drafting responses to health authority questions and negotiating CMC positions in submissions, meetings and pre-approval inspections.
- CMC investigation and problem resolution
- — Applies chemistry and biotechnology expertise to investigate manufacturing and control problems for API and drug products, driving OOS, OOT, stability and deviation issues to root cause.
- Luminata CMC decision support
- — Uses Luminata (ACD/Labs) to consolidate process, analytical and impurity data and manage CMC decision-support and control-strategy justification across the drug-development lifecycle.
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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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