Director, CMC Product Development - Molecule

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact.

Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

The Director, CMC Product Development – Small Molecule is a senior technical and operational leader responsible for the end‑to‑end CMC development of small molecule drug product candidates, from early formulation through process development, clinical supplies, and regulatory submission. Reporting to the Executive Director, CMC Product Development, this individual drives the drug product development activities on assigned programs. This role carries no direct reports but works cross‑functionally with internal teams and external CDMO drug product partners.

It requires deep expertise in small molecule formulation science and manufacturing, experience in taking programs through late‑stage development and filing, and ability to make sound technical decisions in a pre‑commercial biotech environment.

Hybrid
- This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week — currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.

• Define and execute drug product development strategy for assigned small molecule programs, including formulation approach, manufacturing platform, and the development roadmap required to support the clinical and regulatory plan.
• Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing.
• Direct and oversee drug product process development, technical transfer, scale‑up, process optimization, registration batch execution, and process validation / PPQ for solid oral dosage forms (tablets, capsules) and other small molecule drug delivery systems.
• Serve as the primary technical interface with CDMO drug product teams for assigned programs, defining the scope of activities, providing scientific oversight of formulation and manufacturing campaigns, document review, and deviation resolution. Hold partners accountable to quality and timeline commitments.
• Author and review drug product sections of regulatory submissions (IND, IMPD, NDA, MAA) including formulation descriptions, manufacturing process narratives, container‑closure justifications, control strategies and process validation approaches. Lead the technical response to FDA and EMA questions on drug product topics and support health authority meetings.
• Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into formulation and process development decisions, establishing critical quality attributes (CQAs), critical process parameters (CPPs), and design spaces.
• Collaboration with Analytical Development to define drug…