Senior Director, Analytical Research & Development

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 CDMOs, 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.