Senior Director, Analytical Research & Development

The role

This person will lead analytical research and development for a small molecule portfolio targeting neuropsychiatric disorders. They will provide strategic and technical leadership from pre-clinical to late-stage clinical development.

What you will do

• Serve as the functional head of Analytical Research & Development
• Define and implement phase-appropriate analytical development strategies for drug substance and drug product
• Lead and develop the Analytical function within CMC including direct management of analytical staff
• Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer
• Define and execute outsourced analytical strategy including selection and management of CDMOs and contract testing laboratories
• Provide strategic oversight and day-to-day governance of CDMOs
• Provide technical leadership for analytical method development, validation, and transfer
• Ensure analytical methods and specifications are scientifically justified and compliant
• Review and approve analytical methods, validation protocols, analytical reports, and stability protocols
• Oversee stability programs

Required 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
• 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
• Willingness to travel internationally approximately 25% of the time

Nice to have

• Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft-gel dosage forms)

Benefits

• total rewards (monetary and non-monetary) program

About the company

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company uses its proprietary Glyph technology platform to advance clinically validated mechanisms.