A versatile site manager specializing in contract manufacturing (CMO) collaboration, process development, and relationship management with external suppliers on syringe filling, assembly, packaging, external sterilization, and serialization. Over 20 years of experience in developing injectable devices for monoclonal antibodies/proteins. Proficient in API processing from drug substance to drug product (i.e. bulk handling, freeze/thaw, filtration, compounding, aseptic fill-finish, secondary packaging, and terminal sterilization). Successfully obtained FDA approval of two ophthalmic products within project timeline. Supported IND, PAS, BLA, and MAA filings on multiple injectable devices in ophthalmology and immunology. Recognized as an exceptional performance team member who delivers results on target. Excellent track record of delivering results and holding positions with increase in responsibilities. Capable of developing and implementing infrastructure / business processes for global tech transfers.
Listed skills include Process Simulation, Technology Transfer, Biotechnology, Design Of Experiments, and 12 others.