Director/Senior Director, Analytical Development

Head of Analytical Development: NYC

Position Overview

We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities.

This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners.

Key Responsibilities

• Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product.
• Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization.
• Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements.
• Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables.
• Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met.
• Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability.
• Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed.

Qualifications

• Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization.
• Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred).
• Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings.
• Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment.
• Willingness and ability to be onsite in New York 4 days per week.

Why Join?

• Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs.
• Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization.
• Collaborative, science-driven culture where your contributions make a tangible difference.