Peter Knauer has over thirty years of CMC leadership experience in the Biomedical Industry. Peter has served as Vice President of CMC/RA as well as QC/Analytical for US and International based companies such as Xeris Pharmaceuticals, British Technology Group (BTG), Protherics, Jade Therapeutics, Symic Biomedical, and BioUtah. Peter started his career at Genentech, Inc. where he held numerous leadership and technical positions in pharmaceutical development and drug delivery. Peter has directly overseen multiple NDA/BLA approvals and 510(k)/PMA clearances. Peter holds a Master’s Degree in Mechanical Engineering and a Bachelor’s Degree in Materials Science Engineering.Specialties:- Chemistry, Manufacturing and Control (CMC)- Regulatory Affairs- Quality Control / Analytical - Combination Products- FDA Regulations- Regulatory Submissions (INDs, IDEs, NDAs/BLAs, 510Ks) - Quality Management Systems (QMS) - Quality Control- Process Validation (QbD/DOE)- Contract Manufacturing - Process Development / Scale-up- Risk Management- CAPA- Audits- Compliance- Supplier Management- Biologics- Small Molecules- Drug Delivery Systems- Medical Devices