Senior Director, Analytical Research & Development

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. This position is based in Boston's Seaport area, with a strong preference for being onsite 4 days per week. 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.