Director, Analytical Chemistry
Fulcrum Therapeutics
5 months ago
Remote friendly (Cambridge, MA)
United States
Operations
Director of Analytical Chemistry
Description
- Reporting to the Head of Technical Operations, responsible for the design and execution of control strategies for the manufacture of drug substances and drug products.
- Provides technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers.
- Collaborates with pharmaceutics on pre-formulation activities.
- Collaborates with QA on OOS and OOT investigations and CMC risk management.
- Helps Reg-CMC author relevant sections of regulatory filings.
Key Responsibilities
- Provide technical leadership to CMOs and CROs for drug substance and drug product process development, including cGMP method development, validation, method transfer, method remediation, data analysis, and reporting to ensure compliance with GCP, GLP, and cGMP standards.
- Collaborate with Drug Substance, Drug Product, QA, and Reg CMC to ensure cross-functional, phase-appropriate, on-time plans.
- Design and manage stability studies, including shelf-life and retest date management, to ensure seamless clinical supply.
- Lead and manage reference standard, in-process control, and specification strategies across the pipeline.
- Review and approve documents at CMOs (Test Methods, Qualification/Validation Protocols, Specifications, Reports, etc.).
- Generate, review, and approve DS/DP control documents for regulatory submissions (IND/IMPD and NDA/MAA).
- Visit contract manufacturing sites domestically and internationally to support key production milestones.
Qualifications
- MS with 15+ years or PhD with 10+ years of relevant experience developing and applying analytical control strategies for both drug substance and drug product.
- Expert in developing QC test methods using advanced analytical techniques (UPLC, GC, MS, PSD, etc.).
- Proficient at troubleshooting analytical methods at CMOs.
- Proven leadership in phase-appropriate analytical control strategies from early development through pivotal studies.
- Knowledgeable in Regulatory CMC and ICH guidance.
- Highly effective collaborator with DS/DP, QA, and RA stakeholders.
Skills/Personal Requirements (from description)
- Positive work presence; responds to stress and ambiguity with humor.
Compensation
- Base Salary Pay Range: $240,000—$240,000 USD
Description
- Reporting to the Head of Technical Operations, responsible for the design and execution of control strategies for the manufacture of drug substances and drug products.
- Provides technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers.
- Collaborates with pharmaceutics on pre-formulation activities.
- Collaborates with QA on OOS and OOT investigations and CMC risk management.
- Helps Reg-CMC author relevant sections of regulatory filings.
Key Responsibilities
- Provide technical leadership to CMOs and CROs for drug substance and drug product process development, including cGMP method development, validation, method transfer, method remediation, data analysis, and reporting to ensure compliance with GCP, GLP, and cGMP standards.
- Collaborate with Drug Substance, Drug Product, QA, and Reg CMC to ensure cross-functional, phase-appropriate, on-time plans.
- Design and manage stability studies, including shelf-life and retest date management, to ensure seamless clinical supply.
- Lead and manage reference standard, in-process control, and specification strategies across the pipeline.
- Review and approve documents at CMOs (Test Methods, Qualification/Validation Protocols, Specifications, Reports, etc.).
- Generate, review, and approve DS/DP control documents for regulatory submissions (IND/IMPD and NDA/MAA).
- Visit contract manufacturing sites domestically and internationally to support key production milestones.
Qualifications
- MS with 15+ years or PhD with 10+ years of relevant experience developing and applying analytical control strategies for both drug substance and drug product.
- Expert in developing QC test methods using advanced analytical techniques (UPLC, GC, MS, PSD, etc.).
- Proficient at troubleshooting analytical methods at CMOs.
- Proven leadership in phase-appropriate analytical control strategies from early development through pivotal studies.
- Knowledgeable in Regulatory CMC and ICH guidance.
- Highly effective collaborator with DS/DP, QA, and RA stakeholders.
Skills/Personal Requirements (from description)
- Positive work presence; responds to stress and ambiguity with humor.
Compensation
- Base Salary Pay Range: $240,000—$240,000 USD