Provided technical and managerial support to the cross-functional CMC teams responsible for the company’s two leading biopharmaceutical assets at selected drug product (DP) contract manufacturers (CMOs). Provided technical oversight for clinical batch manufacturing and drug product/process validation, including review/approval of batch records, protocols and reports, change controls, deviations, etc. Authored development and manufacturing (CMC) sections of supporting regulatory submission documentation (IND/IMPD/BLA/MAA/etc.) and responses to associated agency inquiries.

Provided technical support to Global External Manufacturing Operations group for the commercial manufacture of multiple sterile biopharmaceutical drug products (monoclonal antibodies and therapeutic proteins) across a global network of CMOs.Provided fill/finish expertise to cross-functional teams responsible for the scale-up and technical transfer of commercial sterile biopharmaceutical products and fill/finish processes between sites.Provided fill/finish expertise and managerial support (auditing, scheduling, logistics, documentation review/approval, etc.) to CMC teams in the selection of domestic CMOs and subsequent manufacture of parenteral pre-clinical/clinical supplies.Provided technical leadership for the qualification of new, pilot-scale fill/finish equipment in the Global Technical Support group. Managed pilot-scale fill/finish facility for the production of commercial reference standards, research reference standards, and toxicological study materials.

Provided technical support and CMC services to commercial Manufacturing Operations (internal and CMOs) for the production of sterile, small molecule drug products, including scale-up, tech transfer, validation, and life-cycle management. Developed and implemented new products, processes, equipment, and technologies to expand markets, improve plant efficiency, increase volume, reduce costs, improve quality, etc.