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

Why Join?