Seaport Therapeutics
Senior Director, Analytical Research & Development
Boston, MA · Director
Sponsorship not specified$230k-$270kDetected 22 days ago
RecruitingPerformance ManagementThermal AnalysisFDA RegulatoryResearchMass SpectrometryAnimal StudiesLeadershipCommunicationCollaborationRegulatory Affairs
About the role
- Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.
- 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.
Responsibilities
- 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.
- Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
- Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.
- Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders.
- 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.
Requirements
- 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).
- Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
- The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
- MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
- Demonstrated ability to lead and influence cross‑functional teams in a fast‑paced, resource‑constrained biotech environment.
- Willingness to travel internationally approximately 25% of the time.
Compensation
- The expected salary range for this role is $230,000-$270,000, with the final offer based on experience, market data, and internal equity.
Benefits
- 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.
Company info
- At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration.
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