Paul Chen

About Paul Chen

Experienced analytical chemist in Pharmaceutical field

Experience

1. Senior Scientist

   Pharmedium Services

   Nov 2016 — Present · Memphis, TN, US

   Perform quantitative and qualitative analysis of sterile compounded admixed injectable products for distribution to customers nationwide. Ensuring laboratory testing and documentation meets regulations; CFR Title 21 Part 210, and 211. Train personnel in aseptic technique.• Lead data reviewer for cGMP compliance and scientifically sound data analysis (e.g, controlled laboratory forms, notebooks, and logbooks) • Author technical reports and SOPs for analytical testing and instrument operation• Review, approve and issue effective SOPs, validation protocol reports• Lead and manage staff to perform analytical laboratory investigations, determine CAPAs, monitor CAPA effectiveness, and author, review and approve re-test protocols (OOS investigations)• Review, issue and execute HPLC/UPLC validation protocols and final reports• Maintain and troubleshoot laboratory equipment (e.g, UPLC, HPLC, UV, KF) • Collaborate with external site departments to coordinate laboratory strategy for QC department projects; communicate and organize QC department strategy with QC /QA management and QC personnel across all shifts (1st, 2nd, 3rd)

Education

• University of Massachusetts Lowell

  Master's degree, Biochemistry

  2002 — 2004

Skills

• Validation
• Glp
• Method Development
• Quality Control
• Gmp
• Cell
• Hplc
• Pharmaceutical Industry
• Sop
• Biotechnology