Sr. Director, Analytical R&D

Work Location: Suffolk County, Massachusetts

Summary:

Lead analytical research and development for a portfolio of small molecule programs, providing strategic and technical direction from pre-clinical through late-stage clinical development. Oversee analytical method development, validation, and transfer, ensuring compliance with regulatory standards and uninterrupted clinical supply. Collaborate with cross-functional teams to deliver high-quality analytical solutions supporting regulatory filings and product advancement.

Responsibilities:

• Direct analytical strategy and execution for small molecule programs across all development phases, ensuring alignment with overall objectives.
• Develop and implement phase-appropriate analytical methods for drug substances and products, maintaining scientific rigor and regulatory compliance.
• Manage and grow the analytical team, planning for future capability needs as the portfolio evolves.
• Establish and maintain best practices for analytical lifecycle management, data integrity, and documentation.
• Oversee outsourced analytical activities, including selection, onboarding, and performance management of external partners and laboratories.
• Provide technical leadership in analytical method development, validation, and transfer using advanced chromatographic and spectroscopic techniques.
• Ensure analytical methods and specifications are scientifically justified, phase-appropriate, and compliant with compendial and regulatory standards.
• Collaborate with quality, regulatory, development, and clinical supply teams to ensure seamless integration of analytical activities into overall project plans.

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 settings.
• Proven leadership in analytical development across multiple stages, including late-stage clinical and registration-enabling activities.
• Experience managing analytical teams and executing analytical strategy.
• Expertise in chromatographic and spectroscopic techniques such as GC, LC, IC, chiral separations, and detection methods (UV/Vis, CAD, MS, fluorescence, FID, ECD).
• Experience managing outsourced analytical development and testing activities with contract organizations and laboratories.
• Strong knowledge of global regulatory requirements and ICH guidelines for analytical development and control strategies.
• Experience with complex lipophilic drug substances and enabling formulation approaches (e.g., SEDDS, soft-gel dosage forms).
• Demonstrated ability to lead and influence cross-functional teams in a dynamic environment.
• Excellent communication, collaboration, and scientific judgment skills.
• Willingness to travel internationally up to 25% of the time.

Published Category: Analytical & Process Development