CMC Associate
manufacturing › Chemistry, Manufacturing & Controls (CMC) · S2 — S2 — Support Specialist · Support
An entry-to-mid level individual contributor developing foundational skills in chemistry, manufacturing, and controls documentation and compliance support.
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What this role is
An entry-to-mid level individual contributor developing foundational skills in chemistry, manufacturing, and controls documentation and compliance support. At the Support Specialist (S2) level, the role owns a defined queue or customer set, standard issues within known procedures, and drives customer satisfaction for own queue. None.
What this level does
- Executes multi-step sample-handling, documentation and data-entry tasks for early-phase clinical API and drug product studies, working from general expectations, deadlines and priorities rather than step-by-step direction
- Compiles routine sections of CMC technical reports, protocols and regulatory support documents from templates, recognizing when a record needs correction or an entry deviates from the expected form
- Maintains stability pull schedules and sample inventories, coordinating pulls and logging results across several concurrent studies
- Supports GMP/GLP documentation review by checking records for completeness and correct sign-off, escalating gaps that require judgment
- Knowledge applied
- Broad knowledge of CMC documentation and sample-handling procedures; applies acquired skills across varied, multi-step tasks.
- Complexity & problem solving
- Semi-routine work; recognizes the need for occasional deviation and escalates or flags discrepancies.
- Collaboration & interaction
- Routine peer interaction across lab, QA and study teams; works to general expectations and deadlines.
- Typical experience
- 1–2 years; some related CMC/lab support 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
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
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