CMC Scientist
manufacturing › Chemistry, Manufacturing & Controls (CMC) · P3 — P3 — Mid-Level Professional · Individual contributor
An individual contributor who independently manages chemistry, manufacturing, and controls activities supporting pharmaceutical or biotech product development and manufacturing.
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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 independently manages chemistry, manufacturing, and controls activities supporting pharmaceutical or biotech product development and manufacturing. At the Mid-Level Professional (P3) level, the role owns features or a sub-system end-to-end, adapts existing approaches, and drives project / team outcomes. Mentors juniors informally.
What this level does
- Apply chemistry/biotechnology expertise independently to resolve manufacturing and control problems for API and drug products, owning the investigation of OOS/OOT, stability and deviation issues through to root cause
- Manage execution of CMC documentation including IND, IMPD, post-approval supplements, annual reports and registration renewals, planning the work and its milestones
- Serve as a point of contact for a program's CMC deliverables, coordinating input across analytical, manufacturing and QA to assemble NDA/sNDA/BLA sections
- Draft responses to health authority questions on assigned filings, and review batch records, validation, stability, deviation and CAPA reports for regulatory adequacy
- Lead a technology-transfer or process-optimization project, evaluating identifiable process factors to select the appropriate control approach
- Knowledge applied
- Applies solid CMC expertise across process development, control strategy and submission documentation, working with day-to-day independence and planning own work.
- Complexity & problem solving
- Evaluates identifiable process and analytical factors to resolve diverse investigations and select control approaches independently.
- Collaboration & interaction
- Networks with senior professionals and becomes a program point of contact, including first direct contact with health authorities on assigned filings.
- Typical experience
- 5+ years (BA), 3+ years (MA), or 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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