Testing Development

Kevin Williams

**** ******** ******

Indianapolis, IN 46217

317-***-**** *******@*****.***

• P H A R M A C E T I C A L I N D U S T R Y C O N T R I B U T I O N S

• Developed and published a risk control strategy for setting endotoxin excipient specifications now used by ICH, EMA and FDA

• Developed novel methods for extracting endotoxins from components and drugs

• Authored the book: Endotoxins, 3rd edition, Informa Heathcare, 2007, which is the most widely used reference for endotoxin testing today

• PDA Global Microbiology Conference Presenter (2009 and 2012)

• Sat on ICVAM committee for alternate assay validation

• Participated in Lonza expert technology recommendation and positioning committee

• Participated in Lonza blinded study for recombinant LAL ubmitted to USP

E L I L I L L Y & C O M P A N Y C O R P O R A T E C O N T R I B U T I O N S

• Spearheaded reagent reduction initiative resulting in significant global savings

• Benchmarked major corporate competitor compliance strategies

• Mentored / supervised microbiological assay development group

• Developed “best practice” compliance targets for global microbiology compendial assays

• Veteran of FDA, EMA and other inspections

• Authored query responses to inspection findings

• Switched all drug product testing from gel clot to kinetic testing

• Automation of the bacterial endotoxin test for high-throughput water testing

• Troubleshooting and resolution of suspect contamination events

• Technology Assay transfers to global partners

• Real time monitoring of stopper cleaning equipment prior to purchase

E M P L O Y M E N T

Eli Lilly & Company, Indianapolis, IN

Global Quality Consultant (5/07 – present). Dual primary responsibilities include (a) the development and implementation of new bacterial endotoxin (BET) assays and technologies for candidate and FDA-approved parenteral drugs at the Indianapolis campus, and (b) to consult to Lilly’s global partners regarding the development of platforms, protocols, and equipment for microbiological testing of drug compounds and excipients. Conceived and implemented a high-volume, water-testing robot to perform BET, resulting in greater assay accuracy, the elimination of failed assays, and headcount reduction. Developed and qualified PyroGene recombinant (rFC) fluorescent endotoxin testing for BET, and certified and implemented the use of a portable PAT testing unit. Also, implemented and qualified networked endotoxin CFR Part 11–compliant readers and test software, WinKQCL. Implementation of new technologies includes developing instrumentation, SOPs (methods) and training users.

Lead Scientist, Microbiology Development (4/98 – 5/07). Created and published methods for setting endotoxin specifications for raw materials and excipients based on drug dosage, an industry first that has now become an industry-wide standard practice. Developed proposals for microbiology tests using reduced reagent robotics. Authored FDA query responses regarding endotoxin testing, and investigated significant excursion events, including depyrogenation and assay interference for complex drugs. Mentored and supervised development group.

Microbiology Assay Development Analyst (1/90 – 4/98). Developed and qualified assays/instrumentation for microbial identification (MIDI/API/Vitek), and Sterility Testing (Steritest and Isolator). Also, developed assays for microbial purity and preservative testing, and supervised cleanroom testing.

P U B L I C A T I O N S & P R E S E N T A T I O N S

Upcoming speaker at PDA Global Microbiology Conference (Oct. 2012), “Suggestions for Calculating Non-Compendial Endotoxin Limits for Excipient of Parenteral Products”

Paper: “The BET as a Backdrop for Establishing PAT and RMM Goals,” American Pharmaceutical Review, Nov, 2009.

Presentation: “Bringing BET to the Manufacturing Floor” presented at PDA Global Microbiology Conference, October, 2009, Bethesda, MD.

Authored the book: Endotoxins, 3rd edition, Informa Heathcare, 2007, which is the most widely used reference for endotoxin testing today.

Chapter: “Caveats of Bacterial Endotoxin Testing,” Chapter 3 of Pharmaceutical Contamination Control Practice Strategies for Compliance, PDA Publications, 2007.

Edited and authored chapters of “Microbial Contamination Control in Parenteral Manufacturing,” Marcel Dekker, ed., 2004.

Chapter: “Endotoxin: Relevance and Control in Parenteral Manufacturing,” in Microbial Contamination Control in Pharmaceutical Manufacturing, Marcel Dekker, ed., 2004.

Authored the book: Endotoxins, 2nd edition, Marcel Dekker, 2001.

Paper: “Robotic Screening for Optimum Endotoxin Assays,” Pharmaceutical Technology, May, 2000.

Paper: “Developing an Endotoxin Control Strategy for Parenteral Drug Substances and Excipients,” published simultaneously in Pharmaceutical Technology Asia and Pharmaceutical Technology, 1998.

Differentiating Endotoxin Removal, from Inactivation in Vial Component Depyrogenation Validations, Pharmaceutical Technology, October 1995.

Technical Note: Validation of Endotoxin Removal from Parenteral Vial Closures, BioPharm, June 1994, p. 58.

E D U C A T I O N & P R O F E S S I O N A L A S S O C I A T I O N S

BS, Micobiology, Texas A&M.

Member, Parenteral Drug Association (PDA)

Committee member: “Evaluation of In-vitro Pyrogen Test for BET,” at ICCVAM conference, May, 2008, Bethesda, MD.

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