CMC Associate
manufacturing › Chemistry, Manufacturing & Controls (CMC) · P1 — P1 — Entry-Level Professional · Individual contributor
An entry-level professional who supports chemistry, manufacturing, and controls activities under close guidance from senior CMC staff.
Median pay · United States · annual
$63,829 USD
Typical range ()
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Track
Individual contributor
Family rungs priced
P1 · P2 · P3 · P4 · P5 · P6
Coordinates
3 / 4 spaces
pay@2 · 2026-07
What this role is
An entry-level professional who supports chemistry, manufacturing, and controls activities under close guidance from senior CMC staff. At the Entry-Level Professional (P1) level, the role owns own tasks within a defined component, routine problems with known solutions, and drives own deliverables. None — building the craft.
What this level does
- Collect, record and format CMC data — bench testing results, batch observations and documentation — as an associate scientist or CMC analyst under close supervision
- Build and format Common Technical Document (CTD) modules in preparation for submission in one or several countries under the direction of the CMC Supervisor
- Perform routine documentation tasks such as transcribing batch records and Certificates of Analysis using standard templates and defined procedures
- Execute assigned bench-scale chemistry or QA-associate tasks following detailed written instructions, escalating any anomalies to a senior scientist
- Knowledge applied
- Applies foundational chemistry and documentation knowledge to routine data-collection, testing and CTD-formatting tasks using standard templates and defined procedures.
- Complexity & problem solving
- Handles routine problems with standard answers; anomalies are escalated rather than resolved independently.
- Collaboration & interaction
- Works within a stable internal team, reporting to and taking direction from the CMC Supervisor.
- Typical experience
- 0–1 years; new graduate or intern with a chemistry or life-sciences degree.
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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