Don Bates
Sr Director of Corporate and Development Quality (Horizon was Acquired by Amgen, October 2023) at Amgen
Based in San Francisco, United States
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Seniority
Director
Department
Other
Location
San Francisco
Industry
Biotechnology Research
Company size
39K
Contact information
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d•••••••@amgen.com
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Background
About Don Bates
Professional Summary: o Over 31 years of pharmaceutical and biotech experience in Solid/Liquid Dosage, Transdermal, Small Molecule, Biologics, Vaccines, Inhalation Products, Medical Devices, and Drug-Device Combo products o Wide-ranging and diverse industry experience from some of the largest global companies to small startups o Acquired extensive knowledge in quality issues, inspections, management and system improvements Major Accomplishments: o Led multiple PAI Readiness teams at numerous companies to ensure efficient and successful FDA and EMA inspections o Presided as host or participated as SME during 10+ regulatory inspections including backroom coordination o Established and managed vendor qualification/oversight process at multiple companies with up to 400 vendors per company. o Directed a group of over 50 people at the startup of a new aseptic facility. Oversaw all quality and/or validation activities and deliverables. o Responsible for the consent decree remediation on building, facility and equipment for a site with over people o Established and implemented Quality Management Systems at 6 small to mid-sized companies
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