Associate Director, CMC Product Development – Small Molecule

About the role

Beeline Medicines is seeking an Associate Director to lead CMC product development for small‑molecule drug candidates. This senior pharmaceutical scientist will own formulation and drug‑product process development from early screening through Phase 3 and registration, working closely with CDMO partners and cross‑functional CMC teams.

Key responsibilities

• Lead formulation development, including excipient screening, compatibility studies, and optimization of final drug‑product composition.
• Oversee process development and scale‑up for solid oral dosage forms (tablets, capsules) and other delivery formats.
• Manage technical interactions with CDMO drug‑product teams, including batch record review and deviation resolution.
• Author and contribute to regulatory drug‑product sections for IND, NDA, and other filings.
• Drive technology transfer to manufacturing sites and ensure high‑quality CMC outcomes.

Required profile

• Senior pharmaceutical scientist with hands‑on expertise in small‑molecule formulation science and manufacturing.
• Proven experience managing CDMO technical projects and delivering CMC deliverables in a pre‑commercial biotech environment.
• Ability to work independently, prioritize multiple programs, and communicate effectively with cross‑functional teams.

Required skills

• Formulation development for small molecules
• Drug‑product process development and scale‑up
• Solid oral dosage form manufacturing (tablets, capsules)
• CDMO technical management
• Batch record review and deviation resolution
• Regulatory writing for CMC sections

What we offer

• Hybrid work schedule (minimum two on‑site days per week)
• Opportunity to shape CMC strategy for innovative immunology therapeutics
• Collaborative, science‑driven environment within a fast‑growing biotech