Director, DP MSAT

Each of us cares about someone who will need medicines. That's why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We're looking for a Director, Drug Product (DP) MSAT to define and lead our Manufacturing Sciences and Technology strategy for biological drug products. In this role, you'll serve as the senior technical authority for contract drug product and fill-finish manufacturing, setting the strategic and technical direction for external manufacturing partners across new product introductions, technology transfers, process performance, and complex issue resolution. You'll carry final accountability for batch documentation approval, technical report authorship, sampling plan design, and equipment and process qualification, while holding CDMOs and vendors to rigorous technical and delivery standards. You'll also bridge internal development, procurement, and regulatory functions, shaping raw material and equipment requirements and contributing directly to regulatory filings and agency responses. If you thrive on solving complex technical challenges, leading through influence, and helping a growing biologics program take shape, we'd love to hear from you. H ow you might spend your days Serving as the senior subject matter expert for DP/fill-finish manufacturing processes and technologies, guiding external manufacturing, new product introductions, technology transfers, and the resolution of complex process issues across the biopharmaceutical DP portfolio . Directing technology transfer of drug product manufacturing processes to external manufacturing facilities, from strategy through execution Owning final review and approval of CDMO cGMP batch documentation (master batch records, component specifications, protocols, material specifications, etc.) required to support cGMP production Driving process performance improvement in close collaboration with internal and external teams, setting the technical direction for how performance is measured and advanced Authoring and approving DP technical reports (process characterization, /protocols, and validations) in support of cGMP activities and licensure Directing the development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability, and related activities. Leading equipment selection, qualification, and start-up activities, and ensuring manufacturing partners operate with robust, well-established procedures Providing senior oversight of CDMO investigations, root cause determination, and CAPA identification and implementation for manufacturing deviations Partnering with DP development and procurement teams to define technical requirements associated with raw materials, components, equipment, and services, and holding external vendors accountable to delivery timelines Contributing to the drafting of regulatory filings and providing expert response to regulatory information requests W e'd love to hear from you if You have 15+ years of industry experience in DP development and manufacturing of monoclonal and/or bispecific antibodies, and a bachelor's degree in science or engineering discipline; device and combination product experience a plus You have outstanding command of the scientific and technical principles underlying drug products and aseptic fill-finish operations for vial and prefilled syringe presentations You have deep knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles, and apply sound judgment in ambiguous or high-stakes situations You have significant experience in pre-formulation and formulation methods supporting t pre-clinical and clinical programs You have a track record leading technology transfer and scaling monoclonal antibody processes; experience with late stage development of biologics and lic…

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