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 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.