Director, Analytical Chemistry

20h20 hours ago

Fulcrum Therapeutics

Cambridge, US · Full-time · $240,000 – $240,000

About this role

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules to improve lives of patients with genetically defined rare diseases. Fulcrum is committed to patients with rare hematologic disorders and developing pociredir, a first-in-class small molecule to increase fetal hemoglobin for sickle cell disease. The company seeks a driven and strategic leader to head the Analytical Chemistry function.

Reporting to the Head of Technical Operations, the Director of Analytical Chemistry designs and executes control strategies for manufacture of drug substances and drug products. The role provides technical oversight of all Quality Control activities at DS and DP contract manufacturers. Responsibilities include collaborating with pharmaceutics on pre-formulation and with QA on OOS and OOT investigations.

Collaborate with colleagues in Drug Substance, Drug Product, QA, and Reg CMC to ensure cross-functional, phase-appropriate plans delivered on time. Lead reference standard, in-process control, and specification strategies across the pipeline. Review and approve documents like test methods, validation protocols, and specifications at CMOs.

Generate and approve documents for regulatory submissions including IND/IMPD and NDA/MAA. Visit contract manufacturing sites domestically and internationally to support production milestones and build relationships. Help expand Fulcrum’s portfolio of clinical-stage assets through strategic analytical leadership.

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
Collaborate with colleagues in Drug Substance, Drug Product, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
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 including Test Methods, Qualification/Validation Protocols, Specifications, and Reports 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 business relationships