MS&TAssociateDirector–Biologics

**Job Description** **General Summary** The Associate Director, MSAT Biologics provides technical and strategic leadership to support the successful transfer, scale‑up, validation, and lifecycle management of biologics manufacturing processes. This role serves as a key technical interface between development, manufacturing, quality, and external partners, ensuring robust, compliant, and efficient clinical and commercial operations. The Associate Director is expected to lead complex technical initiatives, mentor MSAT team members, and drive continuous improvement across the biologics manufacturing network. **Key Duties and Responsibilities** * Provide MSAT leadership for biologics drug substance and/or drug product processes across clinical and commercial manufacturing. * Lead and support technology transfer activities from process development into internal and external manufacturing sites. * Serve as a technical subject matter expert during process validation, continued process verification, and lifecycle management activities. * Partner cross‑functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and external CMOs to ensure aligned execution. * Provide technical oversight and root cause analysis for deviations, investigations, and CAPAs impacting biologics processes. * Support regulatory submissions and health authority interactions by authoring and reviewing technical documentation. * Drive continuous improvement initiatives to enhance process robustness, yield, and operational performance. * Mentor and develop MSAT scientists and engineers, fostering a culture of scientific rigor, accountability, and collaboration. **Knowledge and Skills** * Deep understanding of biologics manufacturing processes, including cell culture, purification, formulation, and/or fill‑finish. * Strong working knowledge of cGMP requirements and regulatory expectations for biologics manufacturing. * Proven ability to lead cross‑functional teams and influenc