S5
jf_chemistry_manufacturing_controls_cmc::S5
Lead CMC Specialist

Lead CMC Specialist

manufacturingChemistry, Manufacturing & Controls (CMC) · S5 — S5 — Principal Support Specialist · Support

An individual-contributor expert who leads complex chemistry, manufacturing, and controls activities to ensure product quality and regulatory compliance.

Median pay · United States · annual

$62,559 USD

+62.4% vs S1 on this ladder

Typical range ()

$45,954$85,165

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Key statistics

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5 of 8

Track

Support

Family rungs priced

S1 · S2 · S3 · S4 · S5

19-0000

manufacturing

Coordinates

3 / 4 spaces

pay@2 · 2026-07

What this role is

An individual-contributor expert who leads complex chemistry, manufacturing, and controls activities to ensure product quality and regulatory compliance. At the Principal Support Specialist (S5) level, the role owns function-wide support practice, program-level and systemic support problems, and drives support strategy across the function. Subject-matter authority; shapes the practice.

What this level does

  • Contributes to the creation of new documentation procedures, templates and data-capture standards for CMC records within the group, standardizing how stability, batch and transfer data are logged and compiled
  • Serves as the go-to procedural expert for the most complex, non-routine CMC documentation problems — legacy record reconstruction, multi-site data harmonization, or novel submission formats
  • Facilitates peer execution of CMC dossier compilation across concurrent programs, sequencing document work and resolving procedural conflicts as a working lead
  • Trains and provides ongoing guidance to associates and specialists on GMP/GLP documentation practice, CMC decision-support tools, and trend-analysis compilation methods
Knowledge applied
Highly skilled in CMC documentation practice; contributes to the creation of new procedures, templates and data standards within the specialty.
Complexity & problem solving
Resolves the most complex, novel documentation problems and develops the concepts/techniques others follow.
Collaboration & interaction
Acts as working lead/facilitator across programs; provides guidance to and influences associates and specialists.
Typical experience
6+ years; expert in CMC documentation and data-compilation practice.

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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