Kevin Dorgan
Senior Manager Information Systems at Amgen
- Role
- Senior Manager Information Systems at Amgen
- Location
- Hope Valley, RI, US
- LinkedIn followers
- 500 followers
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
Experience
Senior Manager Information Systems
Dec 2022 — Present · 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
1995 — 1999
Skills
- Process Improvement
- Lc-Ms
- Validation
- Protein Purification
- Technology Transfer
- Capa
- Manufacturing
- Delta V
- Chromatography
- Quality System
- Change Control
- Gmp
- Filtration
- Sop
- Fda
- Purification
- Commissioning
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.