Associate Director Analytical Development

Role: Associate Director, Analytical Development, responsible for implementing analytical strategies supporting Viridian's drug development pipeline from preclinical to commercialization. Responsibilities include managing method development, transfer, validation, and review of analytical data for biologics, especially protein therapeutics and monoclonal antibodies, ensuring compliance with cGMP and regulatory standards. Lead technical guidance, author regulatory submissions sections, and oversee investigations at external CDMO/CRO partners. Requirements: Master’s in biochemistry or analytical chemistry with 10+ years or PhD with 6+ years in analytical sciences; extensive hands-on experience with protein therapeutics, analytical testing, and method validation; familiarity with regulatory filings (INDs, NDAs, MAAs). Preferred: expertise in biophysical/biochemical assays, high concentration or combination products, and BLA/MAA authoring. High-Value: biologics (monoclonal antibodies), analytical development, regulatory documentation, IND/IMPD preparation. Collaboration with cross-functional teams and external partners. Location: Waltham, MA; in-office 3 days/week; up to 10% travel.