Associate Director, Quality Assurance - CMC
Position Summary & Responsibilities
Seaport Therapeutics is a clinical-stage biopharmaceutical 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 GlyphTM 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.
Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director, Quality Assurance CMC to manage GMP quality assurance activities supporting clinical development programs, ensuring compliance with Good Manufacturing Practice (GMP), regulatory requirements, and company policies. This role is instrumental in supporting clinical trials, advancing the development of innovative products, and maintaining a culture of quality across the organization.
The ideal 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.
Summary of Key Responsibilities
- Manages QA resources assigned to supporting cGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports
- Act as the primary liaison with CMC and CMOs to approve master documents and executed records in support of GMP manufacturing for API, drug product, and packaged materials
- Manages the oversight, review and approval of deviations and investigations pertaining to cGMP production and testing
- Coordinate product release activities at CMOs including acting as QA
Key Role Competencies & Evaluation Highlights
Rigorous scientific and strategic scrutiny focused on translational research capability, neurobiology expertise, and clinical pipeline acceleration.
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