Executive leadership for biologics product development shown by successful, phase appropriate commercialization of biotech products. Delivered multiple products and processes throughout both early and late stages of biopharmaceutical development including combination biological drug-devices and small molecule parenteral products. -Process development / formulation for frozen, liquid, controlled release, and lyophilized drug products in cartridges, vials, syringes and devices including preparation of BLA sections for a syringe, lyophilized biologic, and a live vaccine product. -Commercialization CMC strategy for biologics including monoclonal antibodies, vaccines, peptides, conjugate antibodies, fusion proteins including combination product - device strategy. -Scale-up / technology transfer and troubleshooting for Phase I through late stage including CMO selection. Experienced writer of process transfer documents, process characterization protocols, stability studies, and scope of work. -Enjoy commercializing challenging products including aseptic suspensions and vaccines. Experience with transitioning these products into devices. -Regulatory document preparation throughout the product lifecycle: IND through marketing application. -Automated inspection and manual inspection development including validation of inspection equipment for vials and syringes. Member of visible particle USP expert panel for and . Specialties: Leadership, technology transfer, method transfer, protein characterization, comparability, plastic container compatability testing, defect set development, formulation development.

Director Process Engineering @ From September 2015 to Present (4 months) Principal Consultant | Founder @ From September 2014 to Present (1 year 4 months) Greater Seattle AreaDirector, Process Development @ From September 2008 to June 2014 (5 years 10 months) Greater Seattle AreaPrincipal Scientist @ From February 2004 to August 2008 (4 years 7 months) Research Investigator @ From 2001 to 2004 (3 years) Senior Scientist @ From 1995 to 2000 (5 years) Indianapolis, Indiana Area

PhD @ California Institute of TechnologyM.S. @ California Institute of TechnologyB.S. @ Massachusetts Institute of Technology Deborah Shnek is skilled in: Technology Transfer, Protein Chemistry, Validation, Biotechnology, Biopharmaceuticals, Formulation, Monoclonal Antibodies, Medical Devices, IND, Process Simulation, Vaccines, Drug Development, Antibodies, Manufacturing, V&V