Vice President of Analytical R&D

Vice President, Analytical R&D

Location: East Coast (Hybrid)
Industry: Pharmaceutical CDMO

About the Opportunity

Our client, a leading U.S. CDMO, is seeking an accomplished Vice President of Analytical R&D to lead and expand its analytical science, development, and technology functions across sites globally.

This executive role will oversee analytical strategy, innovation, and execution across small molecule development and manufacturing programs, from early-phase development through commercial supply. The successful candidate will ensure scientific excellence, regulatory compliance, and seamless integration between analytical, process development, and manufacturing teams.

This is a unique opportunity to join a high-growth, science driven organization known for its technical depth, strong customer partnerships, and commitment to quality.

Duties & Responsibilities

• Provide strategic leadership for the Analytical R&D function, overseeing method development, validation, characterization, and technology transfer for small molecule APIs and drug products.
• Lead a multi-site team of scientists and technical leaders supporting early development through commercial manufacturing.
• Define and execute analytical strategy to enhance technical capabilities, innovation, and regulatory readiness.
• Collaborate cross-functionally with Process R&D, Quality, Regulatory, Operations, and Business Development teams to ensure project success.
• Drive technical excellence through continuous improvement, scientific innovation, and investment in analytical technologies and instrumentation.
• Oversee compliance with cGMP, ICH, and FDA/EMA guidelines for analytical methods, documentation, and data integrity.
• Serve as a technical authority in regulatory interactions and client communications, providing expert guidance on analytical strategies and problem-solving.
• Foster a culture of scientific rigor, collaboration, and professional development within the Analytical R&D organization.

Qualifications:

• Ph.D. or M.S. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• 15+ years of experience in analytical development within the CDMO, pharmaceutical, or biotechnology industry.
• Proven leadership of large analytical or scientific teams (multi-site preferred).
• Deep technical expertise in small molecule analytical method development, validation, and regulatory compliance (HPLC, GC, LC-MS, dissolution, stability).
• Experience managing analytical support for both drug substance (API) and drug product (oral solid dosage, parenteral, etc.) programs.
• Track record of successful regulatory submissions (IND, NDA, ANDA, DMF)