• Serve as a subject matter expert in PFS process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams • Develop late-phase and commercial launch strategy for PFS development and manufacturing • Oversee drug product tech transfer, process development, and GMP manufacturing operations including person in plant support • Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members • Support phase-appropriate strategies for drug product development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness • Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies • Collaborate with drug product development and device teams to develop drug product presentations in vial, PFS, autoinjector, and advanced delivery technologies • Analyze manufacturing data and identify opportunities for process improvement and optimization • Support formulation and co-formulation development for protein therapeutics, including antibodies • Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations • Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)