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Robert Benda
Sr. Director Commercial Quality Assurance at Puma Biotechnology, Inc.
Robert Benda is a seasoned Quality Assurance Professional with over two decades of experience in the pharmaceutical and biotech industry.
He has an extensive background, accumulating 6 years in a commercial QC laboratory and 15 years in QA Operations focusing on clinical product development.
Robert's expertise spans various product types including biologics, small volume injectables, vaccines, monoclonal antibodies, small molecule solid dosage forms, medical devices, and combination products.
His strengths lie in manufacturing quality oversight, tech transfer, lot disposition, and managing quality systems like deviation, CAPA, change control, complaints, material review board, training, and auditing.
Additionally, Robert has experience in commissioning and decommissioning manufacturing suites, SOP writing, regulatory document review, and overseeing external CMOs and contract laboratories.
He pursued an MBA in Sustainability from Marylhurst University and holds a BA in Biochemistry from the University of San Diego.
Robert Benda has held significant roles in well-known organizations, serving as the Sr. Director of Commercial Quality Assurance at Puma Biotechnology, Inc., Sr. Director of Quality Assurance at ArmaGen Technologies, Director of Quality Assurance Supply Chain at Intarcia Therapeutics, Associate Director of Quality Assurance at Janssen Alzheimer Immunotherapy Research and Development, Associate Director of QA Operations at Elan Pharmaceuticals, and previously worked as a Chemist at Watson Pharmaceuticals.
