KEVIN LY

12316 ? Vista Lake Dr. Tomball, Tx 77377 Cell: 713-391-5972 Work: 908.753.2000 x3045 l1384074@westpost.net

Email: k

RESUME CAPSULE Eleven years? experience in Quality Control Microbiology in fastpace environment with Manufacturing Pharmaceutical and Biopharmaceutical Compani es. Possess superior expertise in Industrial QC Microbiology, lab management an d participate with internal and external audits, and FDA inspections. EXPERIENCE 2007 ? Present G&W Laboratories, Inc. ? Nonsterile Facility ? New Jersey Generic Pharmaceutical specialized in Topical Products. Supervisor of QC Microbiology ? Manage the Quality Control Microbiology Laboratory and supervise six microbiol ogists who perform all microbial analyses in a timely manner. ? Possess extensive knowledge in cGMP, GLP, USP, ICH, and FDA regulatory require ments. ? Microbial Enumeration Test includes raw material, bulk samples, and final fini shed drug products of batch released and stability. ? Participate in Process Validations, Process Development of new products, and e xisting final finished drug products. ? Responsible and oversee all operations of the Microbiology Laboratory and in c onjunction with Manufacturing Operations of batches of drug products. ? Oversee, forecast, and manage the annual budget of Microbiology Lab. ? Oversee daily activities of QC Microbiology Lab. ? Review and approve Validation, Process Validation, and Research Development Re ports. ? Review and approve all microbial test data, data trending. ? Write annual reports of Purified Water, Environmental Monitoring of viable air borne counts and viable particulate in Compressed Air System. ? Create new and revise existing SOPs to reflect current practices. ? Write Validation/IQ, OQ, PQ Qualification Protocols and reports. ? Solid skills in writing deviation reports, OOS reports, aberrant test result r eports, and corrective and preventive actions (CAPA). 2006 ? 2007 Enzon Biopharmaceuticals ? Sterile Facility ? New Jersey Biopharmaceuticals with specialized in Injectable of Therapeutic Internal Drugs. Assistant Supervisor of QC Microbiology ? Report directly to the Manager of QC Microbiology Lab and supervise six staff microbiologists. ? Responsible to maintain safety program and coordinate hazardous chemical and b iowaste destructions in compliance with EPA, CFR 46, 49. ? Oversee the overall and schedule daily activities of the QC Microbiology Lab i n conjunction with Manufacturing Operations. ? Solid knowledge in many microbial testing methods, strong technical skills in trouble-shooting and problem solving regards to microbiology. ? Experience in sterile environment with Classes 100, 10,000, and 100,000 and go wning techniques. ? Solid knowledge in sterilization, autoclaving and sanitization. ? Review test data, data trending reports, and conduct training. ? Review and write deviation reports and OOS reports and corrective and preventi ve actions (CAPA). ? Create new and revise existing SOPs and Validation/Qualification Protocols to reflect current practices. 2001 ? 2006 G&W Laboratories, Inc. ? Nonsterile Facility ? New Jersey Generic Pharmaceutical specialized in Topical Products.

Microbiologist II ? Assist the Supervisor of Microbiology to manage the QC Microbiology Lab. ? Responsible to schedule the daily activities of the lab for all staff microbio logists. ? Conduct various microbial testing includes Microbial Limits Test, Antimicrobia l Effectiveness Test, Environmental Monitoring, Method Validation/Development, Z one Inhibition Bioassays, and Microbial Identifications. ? Perform IQ, OQ, and PQ of new equipment and oversee the annual qualification/c alibration/preventive maintenance program on existing equipment. ? Oversee and maintain destruction of chemical and biological wastes. ? Review and Revise Standard Operating Procedures (SOP?s), review Laboratory Not ebooks/Test Data to ensure proper documentations and adherence to SOPs and in co mpliance with cGMP. ? Write deviation reports, OOS reports, and corrective and preventive actions (C APA). 1999 ? 2001 Synaptic Pharmaceuticals ? Research Facility ? New Jersey Research Associate ? Perform ? Analyze ? Perform abase for PCR (Polymerase Chain Reaction) by Gel Electrophoresis approach. recombinant RNAs? and DNAs? sequencing. Southern and Western Blotting Assays, Conduct research and develop dat enzymatic vectors.

EDUCATION Bachelor of Science in Molecular Cell Biology and Microbiology New Jersey City University ? 1998 REFERENCES Available Upon Request