Associate Director, CMC Synthetic Chemistry

About the role

Beeline Medicines is seeking an Associate Director to lead CMC Synthetic Chemistry for small‑molecule drug candidates. This senior individual contributor will own the design, optimization, and scale‑up of synthetic routes, guiding projects from early development through clinical manufacturing.

Key responsibilities

• Design and evaluate robust, cost‑efficient synthetic routes for small‑molecule APIs.
• Lead process development campaigns, including reaction optimization, solvent selection, intermediate characterization, and safety assessments from lab scale to pilot plant.
• Serve as the primary technical liaison with CDMO process chemistry teams, reviewing batch records and resolving process deviations.
• Author drug substance sections of regulatory filings (IND, IMPD, NDA) and ensure routes are regulatory‑ready.

Required profile

• Senior scientific professional with deep expertise in organic and process chemistry.
• Hands‑on experience managing CDMO relationships and technical oversight.
• Ability to work independently while collaborating across functional teams in a pre‑commercial biotech environment.

Required skills

• Organic chemistry
• Process chemistry
• Synthetic route development
• Scale‑up and pilot‑plant operations
• CDMO technical management
• Regulatory filing preparation (IND, IMPD, NDA)

What we offer

• Hybrid work schedule (minimum two on‑site days per week).
• Opportunity to shape the chemistry program of innovative immunology therapeutics.
• Collaborative biotech environment with strong leadership support.