Kevin Dorgan
Senior Manager Information Systems @Amgen
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WORK HISTORY
Senior Manager Information Systems @Amgen
RI, US
Senior manager of site Information Systems team who own business and automation applications. Team of 5 accountable for system maintenance, reliability, security and innovative solutions for drug substance manufacturing.
EDUCATION
Keene State College
BS, Biology
SKILLS
ABOUT KEVIN DORGAN
Career mission: To work, learn, compete and succeed in the biotechnological industry with a focus on both clinical and commercial manufacturingSpecialties: Tech transferQuality systems-Nonconformance investigations-Corrective/Preventative Action-Change Control-Risk AssessementRegulatory Experience- both PAI and time-based inspections including FDA, EU, PMDA and others- both filing author and review responsibilitiesStart up Operations-Chromatography, Buffer, SIP, CIP & TFFInvestigational Experience-Focus on high profile downstream investigations- Experience with partner/client Operational/scheduling optimizations-Harvest MF/Centrifuge-Liquid chromatography-Viral filtration-CIP/COP-TFF Systems-Buffer operations-Drug Substance filtrationTranslate department goals into strategic initiatives by performing ROI, staffing models and risk profiles to rank and prioritize projects appropriately.Proficient in Processing Automation-Delta V, Millipore, Siemens
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