Associate Director, Drug Substance Process Development

Associate Director, Drug Substance Process Development Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph TM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. We are seeking an Associate Director, Drug Substance Process Development and Manufacturing to join the Technical Operations team. The ideal candidate will have a strong background in process chemistry and manufacturing of small molecule drug substances. In this role, they will lead research development activities and oversee manufacturing at contract organizations to ensure sufficient supply for tox and clinical studies, work closely with Quality, Analytical, Regulatory, and Clinical Supply, provide phase appropriate solutions to meet the program objectives. Key responsibilities include process design, scale-up, and technology transfer in collaboration with Quality and Analytical Services. This role reports to the Sr. Director, API Development and Manufacturing. The successful candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a "we own it" mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston's Seaport area, with a strong preference for being onsite 4 days per week.

Identify and track critical process parameters throughout process and manufacturing development to adequately characterize and measure process/product performance and key quality attributes. Lead Tech-Transfer and validation activities Proactively work to manage vendors with regard to scope, timelines, and deliverables Provide on-site support to CDMO as necessary Present technical data to cross functional teams and senior management as needed Collaborate with Quality on investigation of events and resolve them in a timely manner Serve as SME in preparation of briefing book, IND/IMPD and NDA applications

Working knowledge of the appropriate analytical techniques such as HPLC, LCMS, NMR etc. Experience in API manufacturing associated with small molecules in different phases of clinical development Firm knowledge of regulatory guidance applicable to small molecule drug substance Ability to work in a complex, dynamic, global environment; thinking strategically and balancing both long and short-term priorities Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills Ability and willingness to travel up to 20% globally At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $180,000-$205,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.