SCOPE OF WORK
- Review 50-60 analytical reports (HPLC and mass spectrometry data, characterization and quality testing of the drug)
- Review about 10 analytical method transfer reports (moving test methods between labs, including CDMOs)
- Check that data supports conclusions, numbers are consistent across documents, methods were followed, and GMP/data integrity standards are met
- Remediate gaps in previously completed work
- Work independently and research questions on their own, using existing SOPs as the standard
- Indirect contact with CDMOs only. No contact with regulators.
MUST-HAVE SKILLS
- Hands-on HPLC and mass spectrometry experience (able to judge whether the data holds up, not just check formatting)
- Small molecule drug development experience across the lifecycle (early development through validation to filing)
- Strong GMP documentation review experience
- Chemistry background (chemical compound and analytical expertise)
- SPC (statistical process control / data trending). Note: I am confirming this meaning with the manager.
- Experience reviewing analytical method validation and method transfer documentation
- Comfortable working independently, with about 10+ years in pharma/biotech CMC, QC, analytical or quality
NICE-TO-HAVE
- NDA, IND or CTD Module 3 experience
- Working knowledge of ICH Q2 (method validation), Q3 (impurities) and Q1 (stability)
- Data integrity (ALCOA+) and OOS/OOT investigation experience
- Experience with CDMOs and external testing labs
- Prior remediation or gap-assessment projects
- Familiarity with electronic document and QMS systems
WHO TO LOOK FOR
An analytical chemist or analytical QA/QC reviewer who has moved into GMP document review. Typical titles: Senior Analytical Scientist, Analytical QA Reviewer, QC Documentation Specialist, CMC Analytical Consultant, Regulatory CMC Analytical Reviewer.
Key Responsibilities
Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports
Review GMP documentation for compliance with FDA, EMA, ICH, and other applicable global regulatory requirements
Identify documentation gaps, inconsistencies, and compliance risks and recommend corrective actions
Support QC documentation review activities related to analytical methods, test records, and data packages
Provide QC documentation and quality review support for technology transfer activities, as needed
Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies
Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete
Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics
Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners
Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements
Collaborate closely with CMC, QA, Regulatory Affairs, and external partners
Qualifications
Required:
Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related discipline (advanced degree preferred)
10+ years of experience in pharmaceutical or biotechnology CMC, GMP, or Quality roles
Strong hands-on experience reviewing CMC and GMP documentation
Working knowledge of GMP requirements applicable to drug substance and drug product development
Experience supporting QC documentation, investigations, and data integrity requirements
Demonstrated ability to identify documentation gaps and drive corrective actions
Preferred:
Experience supporting early-stage through late-stage development programs
Experience working with CDMOs and external testing laboratories
Experience supporting technology transfer documentation or QC readiness activities
Experience supporting regulatory inspections or agency interactions
Familiarity with electronic document management systems and QMS platforms