Associate Director, Drug Substance Process Development

About the role

Seaport Therapeutics is a clinical‑stage company developing novel neuropsychiatric medicines using its proprietary Glyph™ technology platform. The Associate Director, Drug Substance Process Development and Manufacturing will join the Technical Operations team, reporting to the Sr. Director, API Development and Manufacturing. The role is based in Boston’s Seaport area with a strong preference for being onsite four days per week.

Responsibilities

• Lead the design, planning, and execution of multi‑step organic syntheses of small‑molecule drug substances.
• Ensure synthetic routes, pharmaceutical forms, and compound properties are suitable for kilo‑lab and plant manufacturing.
• Conduct scenario planning to analyze development strategies, assumptions, and risks.
• Identify and track critical process parameters throughout development and manufacturing to characterize process/product performance and key quality attributes.
• Lead technology transfer and validation activities, collaborating closely with Quality and Analytical Services.
• Manage vendors regarding scope, timelines, and deliverables, and provide on‑site support to CDMOs as needed.
• Present technical data to cross‑functional teams and senior management.
• Collaborate with Quality on investigation of events and ensure timely resolution.
• Serve as subject‑matter expert in preparation of briefing books, IND/IMPD, and NDA applications.

Qualifications

• Degree in chemistry or chemical engineering; advanced degree preferred.
• BS with 12+ years, MS with 10+ years, or PhD with 8+ years of pharmaceutical industry experience.
• In‑depth knowledge of synthetic route development and process optimization.
• Experience with technology transfer and outsourced process development work.
• Working knowledge of analytical techniques such as HPLC, LC‑MS, NMR, etc.
• Experience in API manufacturing of small molecules across various clinical development phases.
• Firm knowledge of regulatory guidance applicable to small‑molecule drug substances.
• Ability to work in a complex, dynamic, global environment, balancing long‑ and short‑term priorities.
• Strong planning, execution, and results‑oriented project management skills.
• Willingness to travel up to 20 % globally.

Pay

The expected salary range for this role is $180,000 – $205,000, with the final offer based on experience, market data, and internal equity.

Schedule

Position is based in Boston’s Seaport area with a strong preference for onsite work four days per week. Travel up to 20 % globally may be required.