Senior Biotechnology Manager with extensive experience in the manufacturing of recombinant therapeutic proteins. Proficient in the application of protein purification techniques (chromatography, ultrafiltration, virus inactivation/removal), and the transfer and scale up of purification processes into a GMP manufacturing facility to support clinical and commercial requirements. Demonstrated ability to schedule, coordinate, and supervise operations in a production environment. Comprehensive knowledge of cGMPs and manufacturing documentation, with expert technical writing skills.Accomplishments:* Supervised team of production and support personnel to manufacture bulk drug substance for biotech products meeting quality compliance and supply the market goals.* Led project sub-team for manufacturing of finished drug product and intermediates for clinical supplies, including managment of inventory, planning and budgeting for manufacturing campaigns, and selection and management of CMOs.*Collaborated with various cross-functional work teams to streamline and improve processes, resulting in reduced cycle times for batch record review, completion of deviation reports, and batch release.* Drafted manufacturing sections of biological license application for two commercial products, as well as annual reports and IND CMC amendments for clinical products.* Served as subject matter expert for downstream manufacturing group during inspections from various regulatory agencies, and provided written responses to inspection observations.