• Lead the formulation development, process development, and manufacturing strategies in the design and implementation of stable formulations of monoclonal antibodies for subcutaneous administration via pre-filled syringe and vials; • Provide oversight of ongoing drug product production for clinical and commercial processes, ensuring supply continuity. • Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met; • Lead the development/optimization of scalable, efficient, and cost-effective formulation efforts; • Responsible for technical leadership in issue resolution with CMO partners, including design of experiments and interpretation of results; • Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. • Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. • Perform due diligence as needed on potential partners for fit synergies with the current portfolio. • Provide oversight to combination product related activities and documentation • Review analytical and clinical data to make scientific conclusions. • Maintain current knowledge of regulatory environment, specifically requirements for CMC sections of clinical registration submissions • Create and review technical documents, reports, and presentations for cross functional teams. • Manage SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices.