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Committee & Speaker Biographies

Committee & Speaker Biographies

15th Annual PDA Global Conference on Pharmaceutical Microbiology

October 19-21, 2020, Online

  • Yeissa Chabrier-Rosello

    Yeissa M. Chabrier-Rosello, PhD

    U.S. FDA
    Dr. Yeissa Chabrier-Roselló is a Senior Pharmaceutical Quality Assessor, in the Division of Microbiology Assessment/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research in the FDA. She has been a sterility assurance and product quality microbiology reviewer, served as a subject matter expert for FDA inspections as well as for different regulatory/compliance cases. Prior to joining the Agency, Dr. Chabrier-Roselló worked in the antimicrobial drug development and medical device fields. Dr. Chabrier-Roselló earned a Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine and Dentistry and a B.S. in Industrial Microbiology from the University of Puerto Rico at Mayagüez.
  • Lynne Ensor

    Lynne A. Ensor, PhD

    PAREXEL International
    Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been a consultant to the biopharmaceutical industry since 2019. Her areas of expertise include sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, regulatory facility compliance, and regulatory policy development. Prior to consulting, Lynne was employed by the U.S. Food and Drug Administration for 21 years. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/Center for Drug Evaluation and Research and was responsible for new, generic, biologic and biosimilar drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Sciences’ New and Generic Drug Product Quality Microbiology staff, and Director of Office of Generic Drugs’ Division of Microbiology. Lynne’s previous experience includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.
  • Leslie Furr

    Leslie A. Furr, MS, SM (NRCM)

    US Pharmacopeia

    Leslie Furr is an Associate Scientific Liaison to the Compendial Sciences-General Chapters group at the United States Pharmacopeial Convention.  She has been with USP since 2018 where she is a liaison to the Packaging and Distribution, Dosage Forms, and Microbiology Expert Committees.  Before becoming a liaison at USP she was an Expert Committee volunteer for the Chemical Medicines group with expertise in antibiotic testing.   She holds a certification from the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Device since 2012.  Prior to working at USP, she was a Senior Microbiologist in the pharmaceutical industry where she spent 14 years in method development, R&D, and manufacturing support for non-sterile products.  She obtained her B.S. in Microbiology from the University of North Carolina at Charlotte and her M.S. in Pharmaceutical Sciences at the University of Florida.

  • Mitch Garber

    Mitch B. Garber, BS, RPh

    bluebird bio
    Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio
  • Candace Gomez-Broughton

    Candace Y. Gomez-Broughton, PhD

    U.S. FDA
    Candace Gomez-Broughton, Ph.D. is a Microbiologist in Branch II of the Division of Biotechnology Manufacturingin the Office of Pharmaceutical Manufacturing at the FDA. She has over 9 years of Biologic License Application (BLA) review experience. She received her undergraduate degree in biology from Spelman College in Atlanta, GA and completed her Ph.D. in Microbiology and Immunology at the University of Illinois at Chicago and post-doctoral training at the University of North Carolina at Chapel Hill. Before joining the FDA, Candace worked as a consultant advising clients on how to effectively execute major capital projects. During her time at the consulting firm she spent many hours in oil refineries, chemical plants, and pharmaceutical manufacturing sites gaining a wealth of knowledge about manufacturing process design and control.
  • Amy McDaniel

    Amy L. McDaniel, PhD

    Bristol-Myers Squibb
    Amy McDaniel is the Microbiology Center of Excellence Leader at BMS, based in New Brunswick, NJ. In this role she oversees microbiology methods globally, and is responsible for bringing new technologies into BMS. Prior to Bristol Myers, Amy worked as a microbiology reviewer at the FDA in CDER, where she assessed applications for sterile pharmaceutical drug products. She also has 18 years of experience in various roles in biotechnology at Pfizer, including QC Microbiology, Manufacturing, Technical Operations, and Quality Assurance. Amy has written numerous articles and given many presentations on rapid microbiology methods and risk assessments in microbiology.

  • Randa Melhem

    Randa F. Melhem, PhD

    U.S. FDA

    Dr. Melhem is a Senior Chemistry, Manufacturing and Controls (CMC) Reviewer in the Division of Manufacturing and Product Quality, Office of Compliance and Biologics Quality at CBER/FDA. In this position Dr. Melhem performs CMC/Facility reviews of Biologics License Applications (BLA) and supplements, and she conducts pre-license and pre-approval inspections of manufacturing facilities for cell therapy products, viral vaccines, plasma derivatives and recombinant products, combination products, and in-vitro diagnostic products regulated by CBER. Additionally, Dr. Melhem reviews Investigative New Drugs (IND), Medical Devices, New Drug Applications (NDA) and supplements for CBER regulated products. Before joining FDA, Dr. Melhem worked in the Biotech industry and in Academia. Dr. Melhem received her PhD from Purdue University, and did her postdoctoral training at the University of Pittsburg, University of Michigan Medical School, and Georgetown University Lombardi Cancer Center.

  • Vineeta Pradhan

    Vineeta A. Pradhan, PhD

    U.S. FDA
    Vineeta Pradhan joined the Food and Drug Administration (FDA) in 2016 and is currently working as a Microbiologist in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at the Center for Veterinary Medicine (CVM). She reviews the pre- and post-approval CMC information of generic sterile injectable drugs for the entirety of the drug application lifecycle. She has experience in moist steam sterilization, aseptic processing, media fills and microbiological testing.

    Prior to joining the FDA, Vineeta worked as an Assistant Professor at the Northern Virginia Community College, Loudoun Campus in Sterling, Virginia.

    Vineeta received her Ph.D. in Microbiology from The Ohio State University.
  • Christine Sherman

    Christine Sherman, BA

    Christine Sherman is a member of the Takeda Global Microbiology Management team and is based in Cambridge, Massachusetts. Within Takeda, her role is supporting Sterilization and Aseptic Processing. Her background in Microbiology consists of supporting facilities that manufacture pharmaceutical products (sterile and non-sterile), biologics, and vaccines. Prior to joining Takeda in 2017, she worked for several microbiology laboratories in the pharmaceutical industry including Johnson & Johnson, Pfizer and later, at Merck in a Sterility Assurance role for the vaccine facilities. In these roles, she was responsible for ensuring product sterility by supporting environmental monitoring, process simulation, and smoke study programs, well as facilitating internal Microbiology Communities of Practice focused on bioburden control. Throughout her career, she has interacted with various regulatory agencies and supported internal audits as a Microbiology SME. She is currently a member of the USP Expert Microbiology Committee.
  • Kim R. Sobien, MBA

    PETNET Solutions | A Siemens Company
    Kim Sobien is currently the Principal Sterility Assurance Engineer for PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., which operates the largest network of PET radiopharmacies worldwide.

    Previously she has served as an Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals. Her pharmaceutical industry career encompasses a breadth of experience with injectable pharmaceutical product Quality and Compliance, including pre-filled syringe generics, radiopharmaceuticals, and parenteral pharmaceutical contract manufacturing.

    Kim has a B.S. in Microbiology from the University of Wisconsin – La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is a member of the Parenteral Drug Association (PDA), past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology, and a member of the PDA Microbial Data Deviations (MDD) Technical Report writing team.
  • Friedrich von Wintzingerode

    Friedrich von Wintzingerode, PhD

    Genentech Inc
    Friedrich is QC Lead of iNeST (individual Neoepitope Specific Therapy) project located in South San Francisco, CA.

    After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany. 

    He joined Roche in 2001 working as Micro lab Manager and Senior Manager on various topics (environmental monitoring, biochemical cleaning analytics, microbiological IPC and analytics for release, endotoxin testing, LER). Friedrich led several Roche-Genentech Micro expert teams (e.g. identification, microbiological testing) and co-chaired the PDA LER Task Force. He chaired and co-chaired several Endotoxins and Pyrogen Sessions at Pharmalab and PDA. Before starting his current position he was Senior Manager at Roche-Genentech Global QC and Head of Roche-Genentech global Endotoxin Expert Group and Roche-Genentech global SME on microbial impurity contaminations and LER.
  • ZivaAbraham

    Ziva Abraham, PhD

    Microrite, Inc.
    Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi towards her Ph.D degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
  • Keira Anderson-King

    Keira F. Anderson-King


    Keira Anderson-King is the Sterility Assurance Specialist for Australia and New Zealand Compounding at Baxter.

    Prior to this role, Keira held the position of Microbiology Quality Manager at ANSTO (Australia's only nuclear reactor) where she was responsible for all Microbiology and Sterility Assurance activities across the radiopharmaceutical sections.

    Keira has over 7 years experience in developing, validating and performing a range of microbiology test methods (including sterility testing, endotoxin LAL testing, particle counting, bioburden testing and water monitoring). This is in addition to developing and maintaining Sterility Assurance programs (including environmental monitoring, depyrogenation, cleaning and disinfection, media fills, operator qualification, clean room qualification and sterilisation).

    Keira has extensive knowledge on the application of Microbiology and Sterility Assurance in the radiopharmaceutical space. Keira has applied this knowledge as part of the Australian Therapeutic Goods Association (TGA) radiopharmaceuticals technical working group, which developed the guidance document 'Manufacture of sterile radiopharmaceuticals labelled with fluorine-18' published in February 2019.

  • Renee Blosser

    Renée S. Blosser, MS

    U.S. FDA

    Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance.

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Linda Boele

    Linda C.L Boele, BSc

    Kite Pharma EU

    Linda Boele joined Kite Pharma EU in the role of Sr. Manager QC Microbiology in September 2018. Linda is very experienced and had several roles in the pharmaceutical/biotech/food industry in the microbiology area. She started in research at LUMC and TNO. After that she had several roles with increasing responsibilities at Eurofins-MicroSafe laboratories. She also worked in Quality Control management positions in both Eurofins and Nutricia medical nutrition in The Netherlands. Linda helped setting up the microbiolgy team for QC, took care of the Microbiology labs but also played a key role in setting up the Sterility Assurance concept in Kite Pharma EU- TCF04.

  • Claire Briglia

    Claire F. Briglia, BS

    Vedere Solutions

    Claire Fritz Briglia, B.S., has over 20 years of experience in industrial microbiology. She began her career as an R&D scientist at American Sterilizer Company (now STERIS Corporation) developing low temperature decontamination and sterilization systems for both healthcare and life science. She then moved into the field as a specialist for vapor phase hydrogen peroxide decontamination and sterilization applications. In 2010, she transitioned into a specialist role at MilliporeSigma supporting microbial testing and monitoring and started her own consulting company in 2019. She has presented at many industry conferences as well as conducted over a hundred end user training sessions. Recently she authored two chapters for PDA’s Handbook on Environmental Monitoring as well as articles for PDA Letter in 2014 and 2015. She is a member of the PDA Letter Editorial Committee and is an instructor for PDA’s Aseptic Training Course.

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    Jessica A. Campbell, PhD

    Jessica Campbell received her PhD in immunology from Washington University in St. Louis in 2009, where she studied mechanisms of viral immune evasion. Following postdoctoral fellowships at Washington University and Pfizer, she joined the Bioassay and Impurity Testing group within the Analytical Research and Development organization at Pfizer in 2015, where she initially focused on development of host cell protein immunoassays and the monocyte activation test (MAT). She currently leads an analytical group that manages the MAT and assays used for the detection of process-related impurities.
  • Reyes Candau-Chacon

    Reyes Candau-Chacon, PhD

    U.S. FDA
    Reyes Candau-Chacon, PhD is a microbiologist in Branch 2 of the Division of Biotechnology Manufactruing (DBM), Office of Pharmaceutical Quality, CDER). DBM evaluates the microbial quality and sterility assurance as well as the facility compliance status of biological license applications. This is conducted in a comprehensive manner and includes reviewing the microbiology aspects of the BLA as well as inspecting the manufacturing facilities. In addition, the division participates in writing guidelines, policies, and procedures.

    Prior to her current position, Reyes worked in the Diagnostic industry developing methods to detect genetic biomarkers in blood circulating DNA and before that, she worked in the Biotech industry developing Molecular Biology tools. Reyes holds a PhD in Biology from the University of Sevilla, Spain and conducted post-doctoral research in Marburg, Germany and at the University of Pennsylvania on transcriptional regulation in yeast and mammalian cells.
  • Arabela Cuirolo

    Arabela X. Cuirolo, PhD

    Kite Pharma EU B.V.
    Arabela joined Kite Pharma EU as QC Microbiology Specialist III. Arabela comes from Argentina and has an extensive background in Research in the Microbiology field with focus on antimicrobial resistance. A few years ago she made the switch to the pharmaceutical world by joining Janssen Pharmaceuticals in Belgium. Over there, she gained experience in a GMP laboratory in the role of Project Manager evaluating and implementing new technologies of global projects. Arabela had contribute to establishing the QC microbiology methods in the new lab and worked on improvement projects.
  • Cheryl Essex

    Cheryl E. Essex, MS


    Ms. Essex is the recognized expert in Contamination Control for Sanofi Biologics manufacturers. She leads a community of Contamination Control and Sterility Assurance leaders from across the global Sanofi network.

    Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering. Over the past 15 years, she has held various positions in Contamination Control and Microbiological Quality Control at established biologics companies, biologics contract manufacturers, and emerging biotechnology firms working in mammalian, microbial and stem cell systems.

    Through the course of her career, Ms. Essex has built strong technical expertise in all aspects of contamination control including facility, utility, and process design, and cleaning validation. She is also well versed in microbiological test methodology and Quality Risk Management.

    Cheryl believes that good control requires a solid foundation of rules, but excellent control requires an understanding of principles applied with good judgment. For this reason, she puts a strong emphasis on awareness and education for front-line staff.

  • Maria Flores

    Maria R. Flores, PhD

    Maria Regina Flores has joined the Pharmaceutical Industry after working in Academia for 7 years. Since 2018, she joined the global Center of Expertise Microbiology at Merck. Within the field of Pharmaceutical Microbiology, she is mainly responsible for design and execution of development studies related to Rapid Microbiological Methods for EM. Regina holds a bachelor’s degree in Biotechnology and a PhD in Biochemistry from Tucuman National University, Argentina.
  • Richard Friedman

    Rick L. Friedman, MS

    U.S. FDA
    Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
  • Helen Gates

    Helen Gates, BSc

    Ecolab Life Sciences

    Helen Gates is a Microbiologist with more than fifteen years’ experience within the Pharmaceutical Industry, holding roles within Microbiology, Quality and Production, supporting the manufacture of sterile and non-sterile active pharmaceutical ingredients. Helen acted as the subject matter expert for topics including contamination control, environmental monitoring, aseptic process and equipment validation and water systems.

    Helen joined Ecolab in 2019 as a Global Technical Consultant for Ecolab Life Sciences, advising on application and use of specialist cleanroom biocides in line with current regulatory guidance and industry best practice.

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    Karen S. Ginsbury, BPharm, MSc

    PCI Pharmaceutical Consulting Israel

    Karen Ginsbury is a pharmaceutical consultant with 30 years experience working in and with the pharmaceutical industry. A UK trained pharmacist with a second degree in Microbiology, from Birkbeck College, University of London, she has a passion for quality and a deep respect for microbes. She is a frequent presenter at events around the world, performs many audits each year and works with companies to set up, maintain and improve their quality systems. Karen is a founder member and past president of the Israel Chapter of PDA, a past member of RAQAB and was co-chair at the founding of the outsourced operations and pharmacopeial interest groups. She is also a past member of the editorial committee of the PDA letter.

  • Stephen Langille

    Stephen E. Langille, PhD

    ValSource, Inc.
    Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection of Parenterals Expert Panel as well as several Parenteral Drug Association technical committees.
  • Willaim Lapps

    William Lapps, Jr., PhD

    Merck & Co., Inc.
    William Lapps, Ph.D. is the Director and Global Regulatory Liaison at Merck for the Ebola Zaire Vaccine, Live, ERVEBOâ„¢. His experience includes more than 21 years in vaccine regulatory affairs primarily supporting development and life cycle management of viral vaccines. Bill has contributed as a Global Regulatory Team Leader on various vaccine programs, including influenza vaccines, live attenuated and recombinant vaccines, inactivated vaccines, recombinant proteins and adjuvants. He led a team to license a Quadrivalent Influenza Vaccine in the United States and internationally, in addition to working on an Adjuvanted Pandemic Influenza Vaccine in collaboration with the United States Biomedical Advanced Research and Development Authority. Bill developed and led strategic communications with worldwide Health Authorities for development and license maintenance. He developed and implemented both clinical and CMC regulatory strategies. Bill received his B.A. in Biology from Temple University in Philadelphia, and his Ph.D. in Microbiology from the University of Tennessee. He performed a post-doctoral fellowship in Molecular Genetics at the Roche Research Center in Nutley, NJ. 
  • Paul Mahan

    Paul B. Mahan, RPh, BCNP

    PETNET Solutions | A Siemens Company
    Paul Mahan received his B.S. degree in pharmacy from the University of Kentucky in 1989. He spent 15 years in hospital pharmacy leadership, community pharmacy ownership and as a regulator for the Kentucky Board of Pharmacy. In 2005 he completed the Authorized Nuclear Pharmacy program at Purdue University and practiced in this specialized pharmacy setting at an independent nuclear pharmacy operation for 6 years. In 2011, Paul took a position with PETNET Solutions in a low energy radiopharmacy venture planned for Knoxville, TN. Shortly after, he filled the role as the facility manager for the Knoxville cGMP manufacturing and PET nuclear pharmacy operation. He maintained this manager position until June of 2015 when he transitioned to his current role as Sr. Regulatory Affairs Specialist. Paul is board certified in nuclear pharmacy and was an Expert Panel member for USP on the creation of General Chapter for radiopharmaceuticals. He is currently an Expert Advisor to both the USP Compounding and Small Molecules Committees and also serves on the Regulatory Affairs Committee for the American Pharmacists Association.
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    Jeanne M. Mateffy, MS

    Amgen Inc.
    Jeanne Mateffy is Chief Microbiologist, Director, Quality Sciences group for Amgen Inc. In her role she acts as a lead subject matter expert for global commercial microbiology initiatives, including sterility testing, bacterial endotoxin testing, bioburden, environmental monitoring, and rapid microbial methods. She is the global process owner for Contamination Control for Amgen, leading contamination prevention initiatives.

    Jeanne joined Amgen in 2011, after having worked for various companies supporting microbiology issues. Most recently she worked for Merck/Schering-Plough in different global and site roles including Director of Water Compliance, which included developing guidelines, engineering standards, auditing and training in order to remediate over 100 water systems across the company. Additionally, she administered the Rapid Microbiology team, was part of the global microbiology group and ran the NJ microbiology laboratories during the Schering-Plough Consent Decree.

    Jeanne has her MS in Pharmaceutical QA & Regulatory Affairs, from Temple University, a master’s certificate in Clinical Trial Management from Drexel University, and a BS in Applied Science & Technology with a concentration in Medical Laboratory Sciences from Thomas Edison State College.
  • Joseph McCall

    Joseph E. McCall, SM (NRCM)

    ADMA Biologics
    Joe McCall, SM (NRCM) is the Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, the University of Tennessee HSC, and providing training at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology for companies in Europe, Asia, South America, and across the US. He has been a proud member of PDA for nearly 20 years and is one of the few ASM Certified Specialists in Pharmaceutical and Medical Device Microbiology on the National Registry of Certified Microbiologists.
  • John Metcalfe

    John W. Metcalfe, PhD

    U.S. FDA

    Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island.  John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003.  At FDA, John works as a microbiologist where he performs a review of both sterile and non-sterile drug products providing an assessment of microbiological quality.  He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding, and is a published author in the area of drug product microbiological quality.

  • Christopher Murdock

    Christopher A. Murdock, PhD

    Esperion Therapeutics
    Chris Murdock, Ph.D. holds a BS and MS in Microbiology from the University of Memphis and a Ph.D. from Rutgers University in Molecular Microbiology.  Chris has over 30 years of industry experience in microbiology and sterile quality in both laboratory and operational roles.  He has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical, biotech and medical device organizations.  Dr. Murdock has extensive experience in sterile quality, aseptic processing, nonsterile manufacturing as well as both development and commercial production.  Dr. Murdock also has extensive experience in compliance and auditing requirements and has supported and led domestic and international Health Authority inspections.  Chris is the current chair of the Pharmaceutical Microbiology Expert Discussion Group and previously served on the USP Microbiology Water Committee.  Chris currently serves as the Co-lead author for the PDA Technical Report TR 13-2, Environmental Monitoring of Facilities Manufacturing Low Bioburden Products as well as the New PDA TRs for Microbial Data Deviation Investigations in the Pharmaceutical Industry.  Chris has also participated as a contributing author on several other Technical Reports.
  • Paula Peacos

    Paula Peacos, MS

    ValSource, Inc.

    Paula Peacos, M.S. has over 30 years of industry experience as a Microbiologist. She has worked in contract manufacturing organizations as well as small, mid-size and large pharmaceutical organizations. Ms. Peacos has extensive experience in aseptic processing, API/drug substance, ATMP and nonsterile production, both clinical and commercial, as well as microbiological laboratory management Ms. Peacos also has extensive experience performing compliance audits internationally as a microbiological subject matter expert. She is an experienced trainer and has developed and implemented customized developmental and remedial programs. In recent years, Ms. Peacos has published several articles and delivered presentations at major industry meetings on topics such as data integrity, root cause analysis and using microbial recovery rates for trending analysis outside of the aseptic environment. Ms. Peacos also currently serves on two PDA Technical Report (TR) Teams. She is a contributing member of the Microbial Data Deviations Team, and Chair of the Environmental Monitoring for Low Bioburden Facilities Team. Ms. Peacos is currently employed as a Senior Consultant ValSource, Inc.

  • Simone Pitts

    Simone E. Pitts, Ms

    U.S. FDA

    Simone Pitts is a National Expert, Pharmaceutical, in FDA’s Office of Regulatory Affairs. Her +20 years of regulatory experience at FDA spans working as a Microbiologist, Domestic Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert, Pharmaceutical. Ms. Pitts is recognized as a global Subject Matter Expert in Biologics, Pharmaceutical, and Active Pharmaceutical Ingredients (API) inspections; and a global industry thought leader in inspectional areas including Process Validation and Data Integrity.

    Over the course of her career, Ms. Pitts developed specialized expertise to conduct and direct highly technical, complex, multi-faceted and in-depth domestic and international inspections and investigations of active pharmaceutical ingredients and finished drug products with extensive experience in areas including but not limited to vaccines, allergenic extract products, antivenins, plasma derived products (and their recombinant analogues), licensed IVD products, gene/cellular therapy products and human cells, tissues and cellular and tissue based products. She holds a bachelor’s degree in Biology and a master’s degree in Microbiology. Ms. Pitts also serves as a training resource for FDA./p>

  • Jim Polarine

    James N. Polarine, Jr., MA

    STERIS Corporation
    Jim Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is the current PDA Missouri Valley Chapter President.
  • Morgan Polen

    Morgan Polen

    Microrite, Inc.

    Morgan Polen is a subject matter expert in the field of contamination control and airflow visualization in cleanrooms. Morgan has over 35 Years of experience working in cleanrooms and controlled environments in many different industries.

    Morgan’s Technical Leadership:

    • Internationally recognized educator in the field of contamination control
    • Member of U.S. Technical Advisory Group to ISO Technical Committee 209
    • Member of ASTM Subcommittee E55.06 Working Group “Guide for Critical Airflow Visualization”
    • Board member of the Institute of Environmental Sciences and Technology (IEST)

    Morgan has been instrumental in drafting and editing international cleanroom standards, contamination control guidelines and best practices. He has extensive experience working on cleanroom projects all over the word. Morgan is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries.

    As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in development of proactive contamination control strategies through pragmatic risk assessment, particle testing and airflow visualization. Morgan’s broad experience troubleshooting contamination issues has helped companies identify and remediate contamination related problems such as:

    • Identify sources of particulate, microbial, fungal, molecular, and electrostatic contamination
    • Assist in FDA 483 observations or warning letter remediation's
  • Dona Reber

    Dona B. Reber, MEd, SM (NCRM)


    • Over 35 years of academic and industrial experience in microbiology labs and mfg support
    • Director/Team Leader, Microbiology and Aseptic Support, Global Quality Operations at Pfizer, assess aseptic processing facilities, investigations, policy documents. Contamination Control, sterile and nonsterile manufacturing support.
    • Lifetime career focus on Microbial Identifications - how they can direct investigations to determine root cause. “Know Your Enemy.”
    • PDA member, working on TR for Contamination Control, TR13 revision
    • PMEDG Past Chair
    • Publications/presentations: environmental monitoring, microbial identifications and microbiology risk assessments. PDA book: Microbial Identifications: The Keys to a Successful Program, 2012, Microbial Identifications: Strategies, Methods and Applications, 2018.


  • Johannes Reich

    Johannes M. Reich, MA, PhD

    Microcoat Biotechnologie GmbH

    Dr Johannes Reich is Managing Director at Microcoat Biotechnologie GmbH in Germany where he is responsible for Endotoxin and Pyrogen test services. Johannes actively engages with the regulatory and scientific community through participation in dedicated working groups, presentations and publications in peer-reviewed journals. He has published in respected journals on endotoxin assays and Low Endotoxin Recovery (masking), and is internationally known for his expertise concerning the phenomenon of low endotoxin recovery in biopharmaceuticals. Johannes received his PhD in Chemistry from the University Regensburg in Germany.

  • J. Kevin Rice

    J. Kevin Rice, PhD

    U.S. FDA

    J. Kevin Rice has worked within the Division of Manufacturing Technology (DMT)/Office of New Animal Drug Evaluation (ONADE) at the US FDA for 13 years. His focus areas are sterile injectable drug product review, in-use stabilty studies for multi-dose injetable animal drug products, and container-closure systems for injectable animal drug products.

  • Ruth Roeder

    Ruth Roeder

    Microcoat Biotechnologie GmbH
    Ruth Roeder studied Biochemistry at the LMU in Munich. After she has received her PhD, she joined Microcoat in 2016. Recently Ruth was appointed Division Manager for Endotoxin and Pyrogen test services at Microcoat.
  • Donald Singer

    Donald C. Singer, MA

    Ecolab Life Sciences
    Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member since 2000. Don is also a member of the European Pharmacopeia Group 1 Microbiology Committee. He was co-chair of the PDA Task Force for the Technical Report 86, “Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing”, and was co-author of the TR 67, “Exclusion of Objectionable Microorganisms”, and is a member of the PDA Task Force for “Contamination Control Strategy” TR. He is a Certified Pharmaceutical GMP Professional (ASQ) and Certified Specialist Microbiologist (NRCM), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.
  • Ed C. Tidswell, PhD, BSc

    Merck & Co., Inc.

    Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck.  This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division.  His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk API manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines.  Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing.  From 2013-2019 he served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board.  In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance, and Co-chairs USP's Modern Microbiological Methods program.

  • Thomas Walker

    Thomas Walker, BS

    Novartis Pharmaceuticals
    Thomas Walker is a Senior Quality Assurance Manager for Novartis Pharmaceuticals. He has been with Novartis for 28 years. In his current role, he serves as the quality representative for the new integrated isolator filling and lyophilization line. Mr. Walker has had multiple professional affiliations during his career including PDA and ISPE. He has presented webinars for Novartis on topics including cleanroom design and operation, cleanroom cleaning and disinfection and disinfectant efficacy testing. Mr. Walker graduated from the University of Texas at Arlington with a Bachelor of Science degree in Biology.  When not working, he enjoys family time, flying, beekeeping and traveling.
  • Laura Wasil

    Laura R. Wasil, PhD

    U.S. FDA

    Laura R. Wasil is a microbiology assessor in the Office of Pharmaceutical Manufacturing Assessment at the U.S. Food and Drug Administration, where she reviews the sterility assurance information in New Drug, Abbreviated New Drug, and Investigational New Drug applications. She received her Bachelor of Science degree in Microbiology from the University of Pittsburgh in 2004, and her Doctor of Philosophy degree in Infectious Diseases and Microbiology from the University of Pittsburgh Graduate School of Public Health in 2012. She has also served as a lecturer in the topics of molecular biology and genetics at the University of Pittsburgh School of Health and Rehabilitation Science, Physician Assistant Program since 2012. Laura joined the U.S. Food and Drug Administration in 2017, and has been involved in the review of applications for Positron Emission Tomography (PET) and other radiopharmaceutical drug products.

  • Scott Weiss

    Scott E. Weiss, BS

    Johnson & Johnson

    Scott earned a Bachelor of Science degree in Microbiology from Texas Tech University and has over 25 years of experience in microbiology and sterility assurance. Scott's experience is with medical devices, combination products, and tissue products. He has developed and established methods with internal and external laboratories for product evaluation including endotoxin testing, bioburden recovery, environmental monitoring and control for manufacturing, qualification and control of aseptic processes, troubleshooting environmental and bioburden failures. His sterilization experience includes cycle development, validation and routine control of steam, dry heat, vaporized hydrog! en peroxide, ethylene oxide, gamma, e-beam, and liquid chemical processes. He has worked on facility design for clean room / controlled environment and sterilization construction, which included design and validation of isolator technology for aseptic transfer. The Director Industrial Microbiology provides overall direction of the Industrial Microbiology function globally for Johnson & Johnson Microbiological Quality & Sterility Assurance (JJ MQ&SA). He leads and directs research related activities in the area of Industrial Microbiology to support the technical needs for Enterprise wide initiatives, as well as those of MD, Pharma and Consumer.