Associate Director, Projects & Strategy, Analytical Sciences & Technology (AS&T)

Role: Associate Director, AS&T Projects & Strategy, overseeing analytical activities for late-stage monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). Objectives: ensure alignment of analytical development with regulatory and commercial goals, coordinate internal and external analytical efforts, and manage documentation for regulatory submissions. Responsibilities: serve as the primary analytical interface within cross-functional CMC teams, shape analytical control strategies, oversee analytical deliverables, and maintain end-to-end ownership of CMC Module 3 dossier components. Requirements: advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related; 10+ years in regulated pharma, with extensive experience in analytical development for biologics, especially mAbs and ADCs; strong knowledge of FDA and EMA regulatory frameworks, GMP, and quality standards. Preferred: proven leadership in late-stage analytical projects, experience supporting regulatory filings such as BLA, and familiarity with pre-approval activities. High-Value: biologics (mAbs, ADCs), late-stage (preclinical through commercialization), CMC analytical development, regulatory compliance, cross-functional collaboration, and global team experience. WorkSetup: full-time, based in Gaithersburg, US, with potential for global stakeholder engagement.