Michael J. Melone
Process Validation
- Role
- Process Validation Manager at 辉瑞
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
OperationsView LinkedIn profile
Experience
Process Validation Manager
Apr 2019 — Present · Sanford, NC, US
Education
Rutgers University
B.S.
1991 — 1994
CUNY Graduate School of Public Health and Health Policy
M.S.
1994 — 1997
Skills
- Gmp
- Validation
- Sop
- Technology Transfer
- 21 Cfr Part 11
- Lims
- Purification
- Fermentation
- Vaccines
- Pharmaceutical Industry
- Change Control
- Quality System
- Cell Culture
- Aseptic Processing
- Trackwise
- Regulatory Submissions
- Aseptic Technique
- Capa
- Fda
- Computer System Validation
- V&V
- Laboratory
- Biopharmaceuticals
- Biotechnology
- Cleaning Validation
- Standard Operating Procedure (Sop)
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