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™ 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.

Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders.  The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport’s portfolio, from pre-clinical development to late-stage clinical development. This includes oversight of analytical method development, validation, method transfer to CMO’s, and support of regulatory filings, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The role also includes strategic partnering with Quality, Development & Manufacturing, and Regulatory to deliver uninterrupted clinical supplies to enable Seaport’s current and future clinical studies.

The role will be accountable for delivering analytical methods that are phase-appropriate and adhere to the highest scientific standards. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, in addition to several years’ experience overseeing analytical development at CMO’s.

The position is responsible for ensuring that all method development, validation and testing (release, stability, and other) performed on behalf of Seaport is conducted in accordance with the appropriate compendial standards, when available, and is compliant to all regulations and industry phase-appropriate testing standards and standard operating procedures.  The Senior Director will also ensure that all testing and testing services coordinate with all other product development activities so that testing does not fall on the critical path and causes product development delays.

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.

Key Responsibilities:

• Serve as the functional head of Analytical Research & Development, accountable for analytical strategy across Seaport’s small‑molecule portfolio from preclinical through late‑stage clinical development.
• Define and implement phase‑appropriate analytical development strategies for drug substance (DS) and drug product (DP), aligned with overall CMC and regulatory objectives.
• Lead and develop the Analytical function within CMC, including direct management of analytical staff and thoughtful planning for future capability needs as the portfolio advances.

• Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer.
• Define and execute Seaport’s outsourced analytical strategy, including selection, onboarding, governance, and performance management of CDMOs and contract testing laboratories.
• Provide strategic oversight and day‑to‑day governance of CDMO’s, ensuring adherence to scope, timelines, quality standards, and data integrity expectations.
• Provide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC‑MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release.
• Ensure analytical methods and specifications are scientifically justified, phase‑appropriate, and compliant with applicable compendial standards and regulatory guidelines.
• Review and approve analytical methods, validation protocols, analytical reports, stability protocols, and stability test reports.
• Oversee stability programs, including trending and proactive identification of potential quality or stability issues.
• Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
• Ensure analytical activities are integrated into overall project plans and do not become a critical path for development timelines.
• Provide analytical CMC leadership for regulatory filings, including INDs, IMPDs, NDAs, and MAAs, with direct responsibility for authoring and reviewing analytical sections.
• Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.

Professional Experience/Qualifications:

• MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
• 12–15+ years of progressive industry experience in small‑molecule analytical development within pharmaceutical or biotechnology organizations.
• Demonstrated experience leading analytical development across multiple development stages, including late‑stage clinical development and registration‑enabling activities.
• Proven experience serving as a functional or sub‑functional leader, including people leadership and accountability for analytical strategy execution.
• Extensive hands‑on expertise in chromatographic and spectroscopic techniques, including GC, LC, IC, chiral separations, and detection methods such as UV/Vis, CAD, MS (SIM/MRM), fluorescence, FID, and ECD.
• Experience managing analytical development and testing activities through CDMOs and contract laboratories in a virtual or highly outsourced operating model.
• Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies.
• Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft‑gel dosage forms).
• Demonstrated ability to lead and influence cross‑functional teams in a fast‑paced, resource‑constrained biotech environment.
• Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
• Willingness to travel internationally approximately 25% of the time.

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 $230,000–$270,000, 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.

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.

Seaport Therapeutics is hiring a Director, Analytical Research and Development, CMC to oversee the analytical method development and phase-appropriate validation of analytical methods for drug substance and drug product in pre-clinical and clinical development. This role reports to the Senior Director, Analytical Research and Development, CMC. In the near term, the role will focus on method development and validation of Phase 1 Phase 2 and early Phase 3 drug substance and drug product candidates.  The role will assist with preparation and review of CMC Regulatory filings. This person will coordinate activities at various CDMO’s to achieve company objectives related to the analytical contribution of process and product development.

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.  Up to 25% travel to CDMO sites will be required.

Key Responsibilities

• Oversee CDMO activites for drug substance and drug product analytical method development, validation and transfer for Seaport Therapeutics as assigned by the Senior Director of Analytical Research and Development
• Represent the analytical CMC function at team meetings with CDMO’s and internal staff.
• Provide strategic oversight and day-to-day governance of assigned CDMO’s including project scope, adherence to timelines, quality, and integrity of data.
• Perform hands-on data review to ensure high-quality data reporting.
• Ensure compliance with regulatory standards, industry guidelines, internal SOPs applicable to the role.
• Support progress at CDMO’s via periodic onsite visits.
• Create and maintain release and stability databases gathered from CDMO stability reports.
• Work with ICH-compliant statistical stability software for stability data trending and shelf life predictions
• Partner cross-functionally with Discovery, Program Teams, Regulatory Affairs, Quality Assurance to support data-driven decision-making and operational excellence at our partner CDMO’s.
• Advise CDMO’s on the analytical tools required to successfully complete method development and validation to industry standards.
• Plan and manage budgets, solicit quotes from vendors, create purchase orders and track spending.

Qualifications

• MS/Ph.D. in Analytical Chemistry or Physical Chemistry and 7+ years in early stage method development, method transfer, method validation for lipophilic drug substances and drug product.
• Demonstrated expertise in analytical development with complex drug substances and drug product formulations
• Experience with drug product formulations utilizing SEDDS in soft-gelatin dosage forms.
• Demonstrated expertise in chromatographic techniques (for example: GC, LC, IC, GC, chiral separations,) employing the following (but not limited to) detectors: UV/vis, CAD, MS (SIM, MRM) fluorescence, FID, ECD.
• Experience with management of CDMO’s for drug substance and drug product for multiple product lines.
• Knowledge of global regulatory requirements, ICH and other relevant guidelines
• Proficiency in the use of Microsoft Office Suite products.
• Excellent communication, collaboration, and leadership skills.
• Comfortable with oversees travel approximately 25% of the time.

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 $198,000-233,000, 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.