Associate Director, Drug Substance Process Development

Seaport Therapeutics; Boston (MA); Hybrid; USD 180,000 - 205,000; Full time

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

Skills

Synthetic chemistry

Process development

Tech transfer

Small molecule API manufacturing

Education

BS in Chemistry or Chemical Engineering

MS in Chemistry or Chemical Engineering

PhD in Chemistry or Chemical Engineering

Tools

HPLC

LCMS

NMR

Job description

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 www.seaporttx.com .

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 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.