Senior Director of Analytical Development

Job Summary

To shape the future analytical operating model for biologics programs, the full-time Senior Director of Analytical Development will lead the strategic direction and execution of analytical development, managing a senior team while engaging in hands-on leadership for critical-path execution in a hybrid work environment.

Key responsibilities

• Define and implement the long-term analytical development strategy and governance structure for biologics from candidate selection to commercialization readiness
• Lead the development and execution of analytical strategies, ensuring alignment with regulatory and quality objectives while managing external partners
• Provide strategic oversight and hands-on leadership during manufacturing campaigns and quality events, including critical technical and GMP issue resolution

Required qualifications

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field with 15+ years of relevant industry experience; or an M.S. with significant additional experience
• Deep expertise in analytical development for biologics, including experience with monoclonal antibodies and protein therapeutics
• Proven track record in developing phase-appropriate analytical strategies and managing CDMOs and contract testing laboratories
• Strong understanding of GMP requirements and quality systems, including experience with deviations, investigations, and inspection readiness
• Demonstrated leadership experience in building and mentoring high-performing analytical organizations in a matrixed environment