Drug Substance Tech Transfer Lead

Role: Lead drug substance technology transfer activities within biologics, focusing on post-approval transfers (including ADCs) and supporting NPI transfers to ensure scalable, reliable commercial manufacturing. Responsibilities: plan, execute, and manage transfer strategies across internal and external sites; collaborate with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, and Engineering teams; embed GMP and quality standards; assess site capabilities and mitigate risks; drive standardization, continuous improvement, and digital innovations in transfer processes. Requirements: Bachelor's, Master's, or PhD in Biochemical Engineering, Biotechnology, or related field; 8+ years in CMC, biologics drug substance manufacturing, or MS&T; strong technical knowledge of upstream, downstream, and conjugation processes; experience supporting biologics portfolios, especially ADCs; proven leadership in transfer projects across diverse modalities; familiarity with GMP, quality systems, and regulatory expectations. Preferred: experience with NPI transfers and digital tools. HighValue: biologics, ADCs, post-approval transfer, NPI support, global manufacturing network, GMP compliance, technical and operational leadership. WorkSetup: not specified; likely matrix environment requiring collaboration.