Drug Substance Process Development Lead

Seaport Therapeutics

Boston (MA)

Hybrid

USD 180,000 - 205,000

Full time

14 days+

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Job summary

Seaport Therapeutics seeks an Associate Director for Drug Substance Process Development and Manufacturing to lead multi-step syntheses for small molecule drug substances. The role oversees external manufacturing partners to ensure sufficient supply for tox studies and clinical trials, collaborating with Quality, Analytical, Regulatory, and Clinical Supply teams.

The successful candidate will guide process design, scale-up, and tech transfer, reporting to the Sr.

Qualifications

Degree in chemistry or chemical engineering with experience in pharmaceutical industry
BS with 12+ years of experience
MS with 10+ years of experience
PhD with 8+ years of experience
Experience with synthetic route development and process optimization
Technology transfer experience with outsourced work
Knowledge of analytical techniques such as HPLC/LCMS/NMR
Experience in API manufacturing for small molecules in clinical development
Regulatory guidance applicable to small molecule drug substance

Responsibilities

Lead design, planning, and execution of multi-step organic syntheses of small molecule drug substances
Oversee manufacturing at contract organizations to ensure supply for tox and clinical studies
Collaborate with Quality, Analytical, Regulatory, and Clinical Supply
Lead Tech-Transfer and validation activities
Manage vendors regarding scope, timelines, and deliverables
Provide on-site support to CDMO as necessary
Present technical data to cross functional teams and senior management
Prepare briefing books for IND/IMPD and NDA applications