Senior CMC Documentation Coordinator
manufacturing › Chemistry, Manufacturing & Controls (CMC) · S3 — S3 — Senior Support Specialist · Support
Experienced support professional who prepares and maintains CMC documentation and records to support pharmaceutical manufacturing compliance.
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What this role is
Experienced support professional who prepares and maintains CMC documentation and records to support pharmaceutical manufacturing compliance. At the Senior Support Specialist (S3) level, the role owns escalated / complex cases, complex or non-standard cases, and drives resolution quality on the team's hardest cases. Guides junior support informally.
What this level does
- Independently carries out moderately difficult CMC documentation tasks — compiling IND/IMPD support sections, annual report data, and stability summaries — exercising judgment on how to present non-standard results
- Investigates and reconciles data discrepancies across batch records, test worksheets and LIMS/log entries, determining what documentation is needed to resolve out-of-trend observations before routing to a scientist
- Coordinates the flow of technology-transfer and manufacturing-readiness documents between lab, QA and external partners, tracking status against timelines with little day-to-day instruction
- Compiles and formats statistical and trend analyses of stability and manufacturing data for scientist review, applying substantial procedural understanding of CMC records
- Knowledge applied
- Detailed knowledge of CMC records and procedures sufficient to perform non-routine documentation and reconciliation tasks independently.
- Complexity & problem solving
- Makes judgments on moderately difficult tasks — reconciling data, deciding presentation of non-standard results — within established procedures.
- Collaboration & interaction
- Coordinates document flow across lab, QA and external partners; little instruction on daily work, no formal leadership.
- Typical experience
- 2–4 years; skilled in CMC documentation support.
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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