Mr. Donald C. Singer is a Senior member of ASQ and a former Chair of the Food, Drug and Cosmetic Division. As a Certified Specialist Microbiologist (NRCM), Don is Global Lead Manager, Microbiology R&D for GlaxoSmithKine. He has been a Malcolm Baldrige Award Examiner and a former National Director, Divisions, on the ASQ Board. He has been a member of the USP Microbiology and Sterility Assurance Committee of Experts since 2000. Don has convened and taught an ongoing series of workshops for industry at the American Society for Microbiology General Meetings. He has been a member of ASQ since 1982, is a Certified Pharmaceutical GMP Professional and has a Six Sigma Green Belt. Don is an active representative for ASQ in the USP Convention, with over 30 years of research, quality control, quality assurance, and laboratory management experience in the pharmaceutical, cosmetic, food, beverage, hospital products and medical device industries. He is an author and editor of books about the laboratory, including two Quality Press books, and he has been an adjunct professor of Biopharmaceutical QC Microbiology at the University of Maryland Baltimore Campus.
Mr. Neil Lewis graduated in Microbiology and Parasitology 1979. He worked 12 years as site microbiologist for Max Factor and Revlon. He is currently responsible for the microbiological performance of some 70 manufacturing sites globally and the development of new microbiological techniques for QC.
Biography will be posted shortly
Mr. Donald English graduated summa cum laude from the University of Charleston with a Bachelor of Science degree in Biology and has a Master of Science degree from North Carolina State University at Raleigh in Microbiology with a minor in Biochemistry. Mr. English has nearly 30 years of experience in industrial microbiology. He is currently the Senior Manager of the R&D Microbiology Laboratory at Avon Products, Inc. in Suffern, New York, USA. He is responsible for supervising the R&D Microbiology Laboratory that conducts the following types of studies: microbiological content testing of raw materials and new product formulations; sanitizer/disinfectant evaluation; validation of laboratory test methods; investigation of new microbiological testing technologies; preservative challenge testing of new prototype product and marketed product formulations; sterilization studies; environmental testing; identification of microorganisms; Quality Control microbiological release testing; and provides microbiological technical support to the microbiology laboratories for the worldwide Avon manufacturing facilities. In addition, he is responsible for establishing corporate microbiological policies regarding Quality Assurance and Good Manufacturing Practices. Before joining Avon, Mr. English worked at Schering-Plough Corporation in the microbiology laboratories of the Research Division and Quality Assurance and at GlaxoSmithKline Consumer Healthcare (formerly the Block Drug Company). Mr. English is a member of the American Society of Microbiology, Society of Industrial Microbiology, Parenteral Drug Association, and AOAC International. In addition, he is an active member of the CTFA Microbiology Committee and the Quality Assurance Committee. He was the past chairperson of the CTFA Microbiology Committee.
Ms. Mary Griffin started MG Quality Microbiology Consulting, LLC after working at Wyeth BioTech (legacy Genetics Institute) quality control microbiology laboratories for nearly 20 years. In her leadership role she ensured the laboratory was at the forefront of rapidly detecting microorganisms and providing accurate, timely and cost effective microbial identifications. She learned firsthand the strengths and weaknesses of these methods and systems for providing robust data. She was actively involved in performing contamination investigations and applying risk assessments; thusly providing a rational approach to support the release or rejection of product. She continues to participate in the evaluation and use of emerging technologies that address microbial detection and identification. Her consulting services strongly embrace her knowledge. She recently taught a PDA TRI course on microbial identifications and presented in the Fundamentals Microbiology Section at the Annual PDA meeting. She holds a M.S. Degree in Microbiology and is certified as a Specialist Microbiologist SM (NRCM) and SM (ASCP). Prior to working in the pharmaceutical industry, she had faculty appointments at the University of Michigan and the University of Massachusetts.
Dr. David L. Pompliano is the CEO of BioLeap, Inc., a drug discovery company driven by next‐generation, computational fragment-based molecular design technology. Formerly a senior pharmaceutical executive from GlaxoSmithKline and Merck, he has 20 years experience in discovery and development of anti-infective and oncology drugs, having been accountable for the pre-clinical credentials for >30 development candidates, of which 4 are now registered medicines (Tykerb, Votrient, Altabax and Promacta). He is also the Principal at Sanderling Consulting LLC, where he assists investors, companies and philanthropies in the evaluation of pharmaceutical assets and in the process of drug discovery and development. Pompliano earned the BS and PhD degrees in Chemistry from the University of Virginia and from Stanford University, respectively, and was an NIH Postdoctoral Fellow at Harvard University.
Biography will be posted shortly
Quality Control Technical Services - Microbiology
Dr. Ed Balkovic is a Principal Scientist in Quality Control Technical Services at Genzyme Corporation, Framingham, MA. He established the lab that is responsible for the identification of all microbial isolates obtained from Genzyme's QC Microbiology testing labs. He conducts special projects and training in the area of Pharmaceutical Microbiology, including numerous studies evaluating new and improved methods for microbial detection and identification. He received his doctorate in Microbiology and Immunology from Baylor College of Medicine, Houston, TX. Prior to joining Genzyme, Dr. Balkovic has held various positions in Quality Control, Quality Assurance, Regulatory Affairs and Research & Development at both emerging biotechnology and established biologics companies. He has extensive experience as a Clinical Virologist and Microbiologist. Previously, he supervised the National Virology Reference Lab serving all of the U.S. Veterans Administration’s Medical Centers. Dr. Balkovic is also an Adjunct Associate Professor in the Department of Cell & Molecular Biology at the University of Rhode Island. He teaches in the areas of Clinical Microbiology & Virology, Vaccine Development, Emerging Infectious Diseases, Biowarfare & Bioterrorism, and Biotechnology Product Development & Evaluation.
Mr. Praful Bhusari studied Microbiology at the University of Wyoming and Management Science at the California State University. He has over eighteen years of experience in Biotechnology, Pharmaceutical and Consumer Product Microbiology. Had the opportunity to work at several companies in the San Francisco Bay area. Since 2001 he is Associate Scientist, in the MedImmune, LLC California site where he has served as the SME for microbiological assay development, rapid technology evaluation, validation and the microbiological aspects of process development.
Development Services Microbiology
Dr. Marian L. McKee is a microbiologist with over 25 years of laboratory experience specializing in infectious disease, bacterial pathogens and toxins. Dr. McKee joined BioReliance as a Principal Scientist in Development Services in January, 2010. Dr. McKee provides the scientific and technical expertise in support of custom and development projects in Microbiology, including Mycoplasma, Sterility, and Bacteriology testing, while working closely with the US Microbiology operational team. Prior to joining BioReliance, she was at ATCC in Manassas, VA where she was Director of Collections from 2004-2009 and managed the microbiology and toxin component of the NIAID Biodefense Repository contract there. Dr. McKee performed her postdoctoral training in the Laboratory of Molecular Biology at NCI, NIH where she remained as a Staff Scientist before joining ATCC. Dr. McKee obtained her PhD in Microbiology and Immunology from the Uniform Services University of Health Services in Bethesda, MD (1995) and her BS in Zoology from Duke University in NC.
President
Ms. Anastasia Lolas is an independent consultant and the owner of Visionary Pharma Consulting LLC. Anastasia provides consulting services to the pharmaceutical industry regarding regulatory and compliance issues related to product quality microbiology of small molecules and therapeutic proteins. Previously, she was a Microbiologist with the Biotech Manufacturing Team in the Division of Manufacturing and Product Quality at CDER/FDA and a Microbiology Reviewer with the New Drug Microbiology Staff in the Office of Pharmaceutical Science at CDER/FDA. In her 6 years at the FDA, Anastasia evaluated many new drug applications and biologics license applications and conducted pre-license and pre-approval inspections of therapeutic protein manufacturing facilities. Anastasia holds a B.S. in Biology from Virginia Polytechnic Institute and State University and a M.S. in Food Science from the University of Illinois at Urbana-Champaign. Prior to joining FDA in 2005, she was employed at Nestlé Waters North America performing microbiological testing of water samples, developing microbiological sampling plans for the manufacturing sites, analyzing data, updating microbiological procedures and developing a training program for plant microbiologists.
Anastasia is the Meeting Chair for the PDA Capital Area chapter and is also a member of the PDA Letter Editorial Committee
Dr. Phil Geis is a native Texan who earned bachelor and doctor of philosophy degrees from the University of Texas. His career in microbiology began in the clinical lab in the US Army, moving to commercial media production and in 1981 to The Proctor & Gamble Company (P&G). Through almost three decades with P&G microbiology, Phil managed preservative and disinfectant development and studies of household and skin microbial ecologies and hygienic manufacturing. He was the first recipient of P&G's namesake award – Dr. Philip Geis Microbiology Quality Award. While at P&G, he also carried responsibilities for state and federal regulatory compliance and policy matters as well as formulation and product development for which he is co-inventor for a number of domestic and international products. Phil has published, lectured and represented P&G's technical interests on subjects of applied microbiology and environmental policy and edited the most recent Cosmetic Microbiology: A Practical Handbook. In 2011, Phil retired from P&G, establishing Geis Microbiological Services in association with Advanced Testing Laboratory. Dr. Geis brings unique global expertise and experience in diverse regulatory, manufacturing, product quality and consumer realities for a broad range of products from OTC drugs to fabric softeners to dog food.
Ms. Cheryl Moser has been with Merck & Co. for 26 years. She is currently a Research Fellow in the Analytical Sciences-Microbiology Merck Research and Development division where she is responsible for the microbiological quality control of pharmaceutical and biological/vaccine products for all research areas. She is experienced with the compendial microbiological and endotoxin assays as well as evaluating rapid technologies. Cheryl began her career with Merck in the vaccine division working in manufacturing and quality control. She later took on responsibilities supervising biochemistry and microbiological laboratories. She implemented a quality control laboratory in the research division and expanded her group's services from sterile and non-sterile pharmaceutical QC into biologicals and vaccines. Prior to her career at Merck, Cheryl worked as a Medical Technologist in hospital laboratories. She holds a BS in Biology/Chemistry, MT Medical Technology, and MS Clinical Chemistry.
Biography will be posted shortly
Dr. Anne Buboltz is a Senior Staff Scientist in the R&D Department at Accugenix, Inc. She is responsible for microorganism library development to improve the coverage, accuracy and robustness of current identification platforms. She evaluates, develops and implements new microbial identification technologies. Anne has a Ph.D. in Biochemistry, Microbiology and Molecular Biology from Penn State University and a B.S. in Biology from the University of Mary Washington. Prior to joining Accugenix, Anne worked as a scientist specializing in microbial genomics, a science writer and project coordinator.
Biography to be posted shortly.
