• Process and product development for parenteral and injectable configurations from early to late stage for both large and small molecules portfolios including three successful ANDA filings for lyophilized products with FDA approvals• Led injectable biologics formulation development from early stage, clinical supplies, to scale-up and technology transfer for BLA filing• Managed the entire stage Chemistry, Manufacturing, and Controls (CMC) and developing commercial ready process for multiple drug/device combination products toward NDA submission• Provided the long-range strategic planning to meet patient-centered needs• Proven track record and hands-on experience in formulation development, fill finish, lyophilization cycle optimization and scale-up, design controls, container closure, extractables/ leachables, packaging, labeling, supply chain logistics, COG to enable clinical supplies, scale-up, and technology transfer • Familiar with combination products development from early to late stage including alternate drug delivery systems, prefilled syringes, and lyophilized vials; in-depth knowledge in controlled drug release technologies• Hands-on experience in QbD, DoE, PAT, factorial study for problem solving• Oversaw suppliers, CPO/CRO/CMO contract organizations; interacted with cross-functional teams including• Familiar with combination products cGMP QSR guidance and CMC regulatory filing for IND, NDA, ANDA, and BLA• Acquired hands-on experience in bio-analytical testing, mechanical and rheological testing, solid state characterization, and protein conformational structure characterization• Oversight of formulation scientists, packaging and device engineers/consultants over development stages until successful technology transfer to the commercialization team