Associate Director, Drug Substance Process Development

Associate Director, Drug Substance Process Development

Associate Director, Drug Substance Process Development and Manufacturing

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. For more information, please visit  .

The Role

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.

Key Responsibilities:

• Lead the design, planning, and execution of multi-step organic syntheses of small molecule drug substances
• Ensure synthetic route, pharmaceutical form, and compound properties are appropriate for kilo lab and plant manufacturing
• Conduct scenario planning to provide analysis and recommendations on development strategy along with associated assumptions and risks
• 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

Qualifications:

• Degree in chemistry or chemical engineering with experience in pharmaceutical industry, advanced degree preferred:
• BS with 12+ years of experience
• MS. with 10+ years of experience
• PhD with 8+ years of experience
• In depth knowledge in synthetic route development and process optimization
• Experience with technology transfer and outsourced work on process development
• 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…