Peter Lee
Manager, Biopharmaceutical Development at Nitto Avecia Pharma Services
Based in Orange County, United States
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Seniority
Manager
Department
Other
Location
Orange County
Industry
Pharmaceutical Manufacturing
Company size
104
Contact information
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p•••••••@aveciapharma.com
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Background
About Peter Lee
18+ years of experience in developing and trouble-shooting immunoassays (ELISA, Luminex, EIA, immunofluorescence assay and immunoblot) and real-time PCR/qPCR assays (SYBR green, TaqMan and Scorpion). 16+ years working in environment supporting compliance to good documentation practice, FDA, GMP, GCLP, GCP, GLP, GDP, ISO 9001/EN 46001 and ISO 13485 requirements. Proven ability to lead a team from assay feasibility to ASR designation, CE marking and 510(k) clearance. Unique experience working in both manufacturing and R&D environments resulting in strong understanding of manufacturing, R&D, QA and QC processes. Extensive experience in design control process, manufacturing transfer, clinical studies for FDA submission, writing both manufacturing and Quality Control SOPs and writing verification/validation protocols and reports. Strong problem solving, trouble-shooting, analytical and communication skills.
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