About the job
Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the quality of life for patients with genetically defined rare diseases. We are steadfast in our mission to provide hope and new treatment alternatives for individuals afflicted by rare hematologic disorders and are actively expanding our pipeline of clinical and preclinical assets. Our flagship clinical asset, pociredir, represents a groundbreaking small molecule engineered to boost fetal hemoglobin expression, offering potential treatment for sickle cell disease and other hemoglobinopathies. We are seeking a dynamic and strategic leader to direct our Analytical Chemistry function as we grow our portfolio of clinical-stage assets.
Position Overview
In this pivotal role, reporting to the Head of Technical Operations, the Director of Analytical Chemistry will spearhead the formulation and implementation of control strategies for the manufacture of drug substances and products within Fulcrum’s developmental programs. The successful candidate will provide expert oversight of all Quality Control (QC) operations at contract manufacturers for drug substances (DS) and drug products (DP). Responsibilities include collaborating with pharmaceutics on pre-formulation tasks, engaging with Quality Assurance (QA) on Out of Specification (OOS) and Out of Trend (OOT) investigations, managing CMC risks, and assisting Regulatory CMC in drafting essential sections of regulatory submissions.
Key Responsibilities
- Deliver technical leadership to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) for drug substance and product development, incorporating cGMP method development, validation, method transfer, method remediation, data analysis, and reporting to uphold compliance with GCP, GLP, and cGMP standards.
- Collaborate with cross-functional teams including Drug Substance, Drug Product, QA, and Regulatory CMC to ensure plans are cohesive, phase-appropriate, and timely.
- Design and oversee stability studies, including managing shelf-life and retest dates, to guarantee uninterrupted clinical supply.
- Lead and manage strategies for reference standards, in-process controls, and specifications throughout the asset pipeline.
- Review and approve a diverse array of documents, such as Test Methods, Qualification/Validation Protocols, Specifications, and Reports at CMOs.
- Generate, review, and authorize documentation related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA).
- Travel to contract manufacturing sites both domestically and internationally to support crucial production milestones and foster strong business relationships.

