Director, Analytical Chemistry
About The Position
Reporting to the Head of Technical Operations, the Director of Analytical Chemistry is responsible for the design and execution of the control strategies for the manufacture of drug substances and drug products for Fulcrum developmental programs. In this position, the successful candidate will provide technical oversight of all Quality Control (QC) activities at DS and DP contract manufacturers. Additional responsibilities include collaborating with pharmaceutics on pre-formulation activities, collaborating with QA on OOS and OOT investigations and CMC risk management, and helping Reg-CMC author relevant sections of regulatory filings.
Requirements
- MS with 15+ or PhD with 10+ years of relevant experience in the development and application of analytical control strategies for both drug substance and drug product
- Expert in the development of test methods that employ advanced analytical techniques for Quality Control (UPLC, GC, MS, PSD, etc.)
- Proficient at troubleshooting analytical methods at CMOs
- Proven track record and leadership in phase-appropriate analytical control strategies from early development through pivotal studies
- Well versed in Regulatory CMC and ICH guidance
- Highly effective collaborator with “customers” in DS and DP, QA and RA
- Positive work presence; responds to stress and ambiguity with humor
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 colleagues in Drug Substance, Drug Product, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
- Responsible for design and management of 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 a broad spectrum of documents (Test Methods, Qualification / Validation Protocols, Specifications, Reports, etc.) at CMOs
- Generate, review and approve documents related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA)
- Visit contract manufacturing sites both domestically and internationally to support key production milestones and build excellent business relationships
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
1-10 employees
