--- title: 'Associate Director, Quality Assurance - CMC at Seaport Therapeutics' canonical: 'https://feeny.ai/job/associate-director-quality-assurance-cmc-seaport-therapeutics-boston-11nqc9m63rgr' type: 'job' last_seen: '2026-09-06' --- # Associate Director, Quality Assurance - CMC at Seaport Therapeutics - **Company:** Seaport Therapeutics - **Location:** Boston, MA - **Posted:** 2026-08-17 - **Last confirmed live:** 2026-09-06 - **Apply:** https://job-boards.greenhouse.io/seaporttherapeutics/jobs/5393100008 ## Job description 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](https://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 approver as necessary - Liaise with Clinical Supply Chain to ensure on-time release of products - Assist with CMC-related regulatory submissions as required - Interacts and communicates with CMC and CMO to assure expectations are established, agreed to, and achieved - Supports the establishment, preparation, and communication of GMP quality metrics. Identifies and works with functional areas as appropriate to facilitate improvements - Supports the preparation of Product Quality Reviews; tracks and trends the performance of validated programs in support of continuous process verification - Other duties as assigned - 10-20% travel to support CMO activities ## Qualifications - Bachelor's degree in Science or related fields - 8 – 10 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function - Strong knowledge of GMP and regulatory requirements, with hands-on experience managing external CMOs - Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment - Small molecule drug development experience highly desirable - Motivated by patient focus and personal commitment to high performance and results - Possesses high integrity and exceptional work ethic 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-$195,000 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. ## About Seaport Therapeutics ## Company Overview - **One-liner**: Seaport Therapeutics is a clinical-stage biotech company developing novel oral prodrugs for depression and anxiety using its proprietary Glyph™ platform to overcome bioavailability and side effect limitations. - **Entity Type**: Private (clinical-stage; raised $340M in funding across Series A, Series B, and a government grant) - **Headquarters**: Boston, Massachusetts, United States - **Founded**: Not publicly available (the company launched as a PureTech Health-founded entity around 2023–2024, based on Series A timing) - **Founders**: Daphne Zohar (CEO), Michael C. Chen (Co-founder, Chief Scientific Officer); the Glyph platform was co-invented by Jamie Simpson and Dan Bonner of Monash University, who are now part of the team. ## Core Business - **Primary industry**: Biotechnology / Neuropsychiatric Drug Development - **Target customers**: Patients with major depressive disorder, generalized anxiety disorder, and other neuropsychiatric conditions; partners and prescribers in psychiatry/neurology - **Mission or purpose statement**: “Unlocking Better Days™” – developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. ## Products & Services - **Glyph™ Platform**: A proprietary oral prodrug technology that enables more medicine to reach the bloodstream and brain while avoiding first-pass liver metabolism and reducing side effects like hepatotoxicity. The platform is licensed exclusively from Monash University. - **GlyphAgo™ (SPT-320)**: Oral prodrug of agomelatine for Generalized Anxiety Disorder (GAD); Phase 1 proof-of-concept data reported in June 2026 show positive multiple-ascending dose results. - **GlyphAllo™ (SPT-300)**: Oral prodrug of allopregnanolone for Major Depressive Disorder (MDD); designed to overcome low oral bioavailability and avoid side effects like sexual dysfunction and weight gain. - **Glyph2BLSD™ (SPT-348)**: Oral prodrug of 2-bromo-LSD, a non-hallucinogenic neuroplastogen for multiple indications including treatment-resistant depression, PTSD, and headache disorders; preclinical stage. ## Market Standing - **Valuation/Market Cap**: Not disclosed - **Key Metric**: **Total Funding** – $340M as of March 2026 - **Notable Investors/Partners**: - Series A (April 2024): $100M led by Sofinnova Investments and ARCH Venture Partners - Series B (October 2024): $225M led by General Atlantic - Grant (March 2026): $15M from ARPA-H - Corporate round (January 2024): undisclosed investor - Strategic collaboration with Monash University (exclusive license for Glyph platform) - **Growth Signals**: - Headcount grew **46.8% YoY** (from ~30 to 52 employees) - Positive Phase 1 proof-of-concept data for GlyphAgo (June 2026) - Active job postings (5 open roles as of mid-2026) - Strong talent inflow from PureTech Health, Karuna Therapeutics, and Bristol Myers Squibb ## Competitive Advantages - **Proprietary Glyph™ platform** that clinically validates mechanisms previously limited by poor oral bioavailability or liver toxicity (e.g., allopregnanolone, agomelatine, 2-bromo-LSD) - **Experienced leadership** with deep history in neuropsychiatric drug development (PureTech Health founders, Karuna veterans) - **First/best-in-class potential** for each pipeline candidate, enabling a pipeline of multiple assets from a single validated platform - **Worldwide exclusive license** to Monash University’s intellectual property, creating a strong IP moat ## Strategic Focus - Advance GlyphAgo into Phase 2 trials for GAD - Progress GlyphAllo and Glyph2BLSD through Phase 1 and toward proof-of-concept - Expand the pipeline into additional neuropsychiatric indications (TRD, PTSD, headache disorders) - Continue hiring across clinical development, CMC, biometrics, and program leadership roles ## Why Work Here - **Mission-driven culture**: Focus on “Unlocking Better Days” for patients with serious mental health conditions - **Location**: Boston Seaport district (101 Seaport, Boston, MA) – a hub for biotech innovation - **Growth trajectory**: ~50% headcount growth in the past year signals a rapidly scaling organization with advancement opportunities - **Team composition**: Small but experienced team (52 employees) with a high ratio of directors/managers (29% director-level), offering exposure to senior leadership - **Flexibility**: Hybrid/office policy not explicitly stated, but the company has a physical office and lists in-person roles; likely offers flexibility typical of Boston biotechs - **Culture highlights**: Featured office tour with CEO Daphne Zohar, an emphasis on collaboration and scientific excellence, and strong ties to PureTech Health’s entrepreneurial ecosystem ## Sources 1. [seaporttx.com](https://seaporttx.com/) 2. [seaporttx.com/our-pipeline/](https://seaporttx.com/our-pipeline/) 3. [seaporttx.com/careers/](https://seaporttx.com/careers/) 4. [LinkedIn – Seaport Therapeutics](https://www.linkedin.com/company/seaport-therapeutics) 5. [job-boards.greenhouse.io/seaporttherapeutics](http://job-boards.greenhouse.io/seaporttherapeutics) ## Other roles at Seaport Therapeutics - [Associate Director, Program Manager](https://feeny.ai/job/associate-director-program-manager-seaport-therapeutics-boston-dsw8wae6kyqh) — Boston, MA - [Bio-Analytical Co-op-Northeastern Students](https://feeny.ai/job/bio-analytical-co-op-northeastern-students-seaport-therapeutics-boston-v2126dtdw6s0) — Boston, MA - [Clinical Trial Manager](https://feeny.ai/job/clinical-trial-manager-seaport-therapeutics-boston-7mer32eraw71) — Boston, MA - [Director, Clinical Quality Assurance](https://feeny.ai/job/director-clinical-quality-assurance-seaport-therapeutics-boston-e2kywkseea5x) — Boston, MA - [Senior Director, Analytical Research & Development](https://feeny.ai/job/senior-director-analytical-research-development-seaport-therapeutics-boston-t9e9pmwrsw0g) — Boston, MA - [Executive Director/Vice President, Clinical Development](https://feeny.ai/job/executive-director-vice-president-clinical-development-seaport-therapeutics-te8jxxh62he1) — Boston, MA