Speaker Biographies

2008 PMF Conference on Microbiology Data Deviation Investigations

Dilip Ashtekar, Ph.D.
Chief Microbiologist and Director of Quality Assurance, Amgen Inc.

Dilip is currently responsible for global Microbiology program and Sterility Assurance at Amgen Inc. He has over 24 years of combined experience in Pharmaceutical, Tissue Engineering, Biotechnology and Vaccine industries. In addition to analytical and microbiological Quality Control (QC), he has significant experience and expertise in Quality Assurance, sterility assurance,  aseptic manufacturing, risk assessment, viral assays, mycoplasma, mycoplasma and bacterial clearance, PCR based assays, development and implementation of rapid microbiological methods and environmental and utilities monitoring programs. In addition, he has over 20 years of experience in mycoplasma assays, mycoplasma and viral contamination control.

Dr. Ashtekar has a strong background in regulatory compliance and extensive experience in remediation of regulatory compliance actions, such as Consent Decrees and Warning Letters.   He started his research and development career as Senior Scientist in the Anti-Infective Drug Discovery Group at CIBA-GEIGY, Basle, Switzerland and later became the Head of Anti-infective Research for Tropical Diseases.  Dr. Ashtekar has a broad work history in pharmceutical industry, with executive positions in several major companies.

Dr. Ashetkar has also authored several patents, book chapters on microbiology related topics in books published by PDA and has contributed to major PDA Task Force efforts (TR13 - Environmental Monitoring and TR33 - Mycoplasma and TR33 - Rapid Microbiological Methods TR33). He has published in excess of dozen publications in anti-infective area in top national and international journals as well as being a frequent speaker at scientific conferences. 

Anita Bawa
Senior Manager, QC Microbiology, Genentech Inc.

Anita has 20 years of experience in the biotechnology and blood bank industries. She has an excellent understanding of cell banking, manufacturing, and quality control testing.  During her career, she has managed personnel and processes in various departments including microbiology, biochemical manufacturing, and component & processing laboratories.

In Blood Bank, she started as a Component Lab Technician and quickly moved to a managerial position and managing the processing and phenotype labs.   In 1997, she transitioned to Genentech, where she started as a Fermentation Supervisor and managed the mammalian cell culture processes and facility environmental testing. Later she managed the E. coli and Cell Culture Fermentation plant and worked with Regulatory and Quality Assurance for routine and new product license inspections. She participated in internal and external audits and inspections.  

Anita currently manages Quality Control Microbiology department and oversees the operations, method validation, microbial identification, and discrepancy groups. She is an active member of ASM, PDA, and PMF.  Anita obtained her Bachelor of Marketing and Management degree from Saint Mary College and Master in Business Administration from the University of San Francisco.

Anne Marie Dixon
Managing Partner, Cleanroom Management Associates

Anne Marie Dixon is the Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.  

She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization. She has trained over 150,000 cleanroom technicians and managers.      

A University of Illinois graduate, she has published over ninety technical articles and three books including How to write a training manual published in 1997 by Micron Video International.   Anne Marie was the first woman to be elected President of the IEST and was appointed to the position of FELLOW in 1998. She is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor.  In addition, Anne Marie is the head of the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments.  

Phil Geis, Ph.D.
The Procter & Gamble Company

Philip A. Geis Ph.D. is a native Texan who earned bachelor and doctor of philosophy degrees in microbiology from The University of Texas.  His career in microbiology began in the clinical lab, moving commercial media production and in 1981 to The Procter & Gamble Company (P&G).  Through over two decades at P&G, Phil has managed preservative and disinfectant development and qualification, the study of household and skin microbial ecologies and manufacturing micro quality.  He has also carried responsibilities for environmental and regulatory affairs and formulation chemistry for which he is co-inventor for a number of domestic and international patents.  He has published, lectured and represented P&G’s technical interests on subjects of applied microbiological and environmental policy and edited the most recent edition of the successful Cosmetic Microbiology: A Practical Handbook.   Phil brings unique global technical experience in diverse regulatory, manufacturing, product quality and consumer realities for a range of consumer products from OTC drugs to salted snacks. 

Victor Ma
Executive Director, Global Quality Systems  

Victor Ma holds a MS of Biomedical Engineering from NJIT and an executive MBA in technology  management.  

His regulatory compliance career starts with Block Drug Company (which now is a part of Glaxo SmithKline) as a Corporate Quality Auditor. Since he joined Novartis in 1998, he has had the responsibilities of auditing, investigation, validation and qualification and PAI preparation in Quality Assurance within the technical development of Novartis. He now heads the Global Quality Systems with the responsibility of building global quality systems and standards.  

In his career, Victor has worked in the field of Drug Regulatory Affairs for handling product registrations in Asia Pacific. He has audited many facilities in Asia, Europe and North America and has managed a number of companywide GMP upgrade projects.  

Karen McCullough

Principle, MMI Associates

Karen Zink McCullough is a veteran of LAL compliance and technology.  She has been working with the bacterial endotoxins test since 1973 and in 1975, she published the first paper on the use of BET in small volume parenterals.  She also was the driving force organizing the LAL Users Group.  Karen is a highly regarded GMP trainer and organizer of professional development programs.   Ms. McCullough holds a Bachelor’s degree in bacteriology from Douglass College (Rutgers University) and a Master’s degree in Molecular Biology from the University of Oregon.   

Frank Settineri
President, Veracorp

Frank Settineri is the founder and president of Veracorp LLC. He has more than 30 years of experience in the pharmaceutical/biotech industry as a microbiology bench scientist, department head, director of operations and strategic analyst. He spent the first fifteen years of his career testing and managing operations within big pharma. In the following years he built technical and business operations for both a small pharmaceutical company and a testing laboratory, developed a start-up pharmaceutical company and grew the international business of a biotech company. Currently he is dedicated to solving microbial contamination problems, reestablishing GMP compliance, preparing personnel for regulatory audits and identifying operational risks for his clients. He also works with business owners to develop loyal employees.

Scott Sutton

Senior Director of Microbiologic Services, Vectech

Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Vectech Pharmaceutical Consultants, Inc.  Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest.  He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000.   He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals.  Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups.  This service also supports two Email lists, the first devoted to pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm) and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).

Tyler Tsang
Manger of QC Microbiology, Genentech, Inc.

Tyler has 12 years of pharmaceutical microbiology experience.  He started his career in a diagnostic company assisting in the development of software algorithms for an automated system used to determine minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of antibiotics.  In 1996, he began working as a Microbiologist at Alza Pharmaceuticals, performing Microbial Limit and LAL testing, and method development for various non-sterile products.  In 1999, he started as a QC Associate at Genentech, performing microbiological testing and method validation of raw materials, in-process samples, and final products.  He has worked with various automated microbial identification systems and has extensive experience with sterility test isolators.  He currently manages lot release operations in the QC Microbiology laboratory.   He obtained his Bachelor of Science degree in Biochemistry at the University of California, Davis

Anethra Wilson
QC Scientist, Imclone Systems, Inc. 

Karen Zimm
Manager, Regulatory Affairs, Johnson & Johnson

Karen R. Zimm is currently a Manager in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API’s and marketed products.  Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products).  She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University.  In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy at Temple University in Philadelphia, PA.