CMC Coordinator
manufacturing › Chemistry, Manufacturing & Controls (CMC) · S1 — S1 — Support Associate · Support
Provides entry-level administrative and documentation support for chemistry, manufacturing, and controls activities.
Median pay · United States · annual
$38,510 USD
Typical range ()
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What this role is
Provides entry-level administrative and documentation support for chemistry, manufacturing, and controls activities. At the Support Associate (S1) level, the role owns a single task type or queue, routine, well-defined requests, and drives individual transactions. None.
What this level does
- Performs routine data collection and sample logging for CMC studies following step-by-step instructions, recording results on prescribed forms and batch/test worksheets
- Assembles and files standard CMC documentation (test protocols, stability pull records, manufacturing worksheets) into the document system per prescribed naming and filing conventions
- Prepares and labels samples for testing under close supervision, following fixed handling and storage procedures
- Enters testing and manufacturing data into logs and spreadsheets, flagging obvious discrepancies to a senior colleague rather than resolving them
- Knowledge applied
- General knowledge of CMC lab/documentation routines — sample logging, form completion, filing conventions; answers are readily available in written procedures.
- Complexity & problem solving
- Routine, prescribed tasks; escalates anything non-standard rather than solving it.
- Collaboration & interaction
- Standard interactions with immediate lab/QA colleagues; completes own assigned tasks.
- Typical experience
- 0–1 years; minimal experience.
Skills at this level
- CMC Documentation Compilation
- — Assembles, formats and files CMC records — test protocols, batch worksheets, stability records, IND/IMPD support sections and submission packages — per naming, filing and completeness conventions.
- GMP/GLP Records Practice
- — Maintains and reviews controlled documentation to GMP/GLP standards, checking records for completeness, correct sign-off and data integrity in a regulated manufacturing environment.
- Sample Logging & Stability Handling
- — Prepares, labels, stores and logs test samples and maintains stability pull schedules and inventories across concurrent CMC studies following handling procedures.
- Data Entry & Discrepancy Reconciliation
- — Records testing and manufacturing data into logs, spreadsheets and lab systems, and investigates and reconciles discrepancies across batch records, worksheets and log entries.
- Statistical and Trend Analysis Support
- — Collects CMC data and compiles/formats statistical and trend analyses of stability and manufacturing results to support resolution of OOS, OOT and manufacturing observations.
- Technology Transfer Documentation Coordination
- — Tracks and routes technology-transfer and manufacturing-readiness documents between internal lab/QA and external CDMO/CMO partners against project timelines.
- Regulatory Submission Support
- — Compiles data and support sections for marketing applications, post-approval supplements, annual reports, registration renewals and responses to health authority questions, resolving cross-document inconsistencies.
- Luminata (ACD/Labs) CMC Decision-Support Software
- — Uses Luminata to organize and connect analytical, process and impurity data across CMC development stages so records and justifications can be compiled and traced for submissions.
- CMC Procedure Development
- — Contributes to the creation and standardization of documentation procedures, templates and data-capture standards for CMC records within the group.
- Working-Lead Guidance
- — Guides and trains less experienced associates on CMC filing conventions, GMP record expectations and documentation workflows while leading the work rather than managing people.
- Cross-Functional Coordination
- — Works within a matrix environment to move CMC documentation and data between R&D, Manufacturing and Quality teams and external partners.
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As of · 2026-07-30
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