PEOPLE INTERVIEWED

While at California State University, she worked on a research project for Standardization of RP-HPLC Methods for the Detection of the Major Peanut Allergens Ara h 1, Ara h 2 and Ara h 3 as her thesis that was published in the Food Chemistry journal.

After graduating from California State University, Poonam worked with Cephazone Pharma, LLC, California as the of Manager Quality Control/Quality Assurance. In this role, she was responsible for conducting disinfectant validation studies, microbial identifications and designing specialized studies for clients.

Poonam joined SGS team as Assistant manager in Special projects and Bioburden in 2017. She oversees design of specialized studies for client specific needs (e.g. disinfectant studies, container closure studies), microbial identification with the 3500 DNA analyzer, and writing dose audit reports per AAMI guidelines and test summaries.

Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

Tony Cundell chaired the PDA task force responsible for the ground-breaking 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science. More recently Tony Cundell co-authored a review article entitled Data Integrity in the Microbial Testing in the September-October, 2017 issue of American Pharmaceutical Review.

Tony Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand.

Experience includes supply chain, quality, lean manufacturing, corporate research & development, product management, developing new and managing existing business.

At bioMérieux, she is today in charge of helping pharmaceutical companies to define and implement next generation microbiology test complying with regulatory guidelines.

Her technical strengths include: Chemical engineering expertise, product development expertise, process model development, technology assessments of process analytical technologies, applied mathematics/data models, and creating hardware and software solutions for gathering better data and enabling streamlined data analysis/data visualization.

She has had the opportunity to develop a strong business background through C-Level leadership positions, including COO and SVP roles at Bend Research (now Lonza), and co-founding Black Canyon Woodworks in Bend, Oregon. She is actively involved in supporting higher education, specific STEM education initiatives, and economic development at the State and National level. Specific efforts include serving as Director on the Oregon Governor's STEM Investment Council (Since 2013) and as Chair of the Oregon Board of Trustees for Oregon Tech University (OIT) (Since 2014).

Lisa Graham received her Ph.D. and B.S. in Chemical Engineering at Oregon State University. She has been a Registered Professional Engineer (53802PE) in Oregon since 2008.

This Branch is responsible for the microbiology product quality assessments of all Biological License Applications submitted to CDER and for the pre-license and pre-approval inspections of biological manufacturing facilities. Dr. Hughes has over twenty years of industry experience in process development and manufacturing and has held various positions in the biotech industry ranging from Senior Scientist to Associate Director of Pharmaceutical Operations. She has been with the FDA for 20 years.

He has held many roles within MilliporeSigma (formerly Sigma Aldrich) during his 20 years of employment with them, most recently as the Head of the Biomonitoring Business Field and formerly as the head of Sales for Global Strategic Accounts. Ian Jennings has an MBA from Universität St. Gallen and a Bachelor’s in Biochemistry from Liverpool John Moores University.

He is a result orientated professional with extensive business experience in pharmaceutical, analytical and bioanalytical chemistry.

He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods within healthcare related industries.

For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller consults with multinational companies in providing technical, quality, regulatory and training solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, environmental monitoring, sterilization and antimicrobial effectiveness.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr, Miller also was the chairperson during the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. He currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College.

She has worked for contract manufacturing organizations as well as small, mid-size and large pharmaceutical organizations. Paula has extensive experience in aseptic processing of clinical and commercial products and biological API/drug substance manufacturing and cell therapy as well as microbiological laboratory management.

In recent years, Paula has published several articles and delivered presentations at major industry meetings on topics such as risk assessment and using contamination rates for trending analysis outside of the aseptic environment. She is currently employed as a Senior Consultant with ValSource, LLC.

He is Head of Microbiology and Bio Products Laboratory; a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course; and acts as an industry consultant. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He has authored over 30 books, 80 book chapters, 100 peer reviewed papers, and 400 technical articles.

She is actively involved in the on-going development and execution of a variety of biologic challenge and interferent test protocols to assess system efficacy and has co-authored a number of technical articles and posters on the subject. She has over four years of additional biologic detector experience gained through work on an infrared-based sensor for use in the detection of microbes in water supplies. She earned her joint doctorate in materials science and engineering from the University of Arizona and in materials chemistry from the University of Rennes.

He is currently chair of the PDA Task Force for the revision of Technical Report,“Pharmaceutical Package Integrity”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and was a Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 35 years of research and development, quality control, quality assurance experience in the pharmaceutical, cosmetic, and food industries. He is a speaker, an author and also currently an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

She has experience using an animal model to study infectious disease. Her core skills include DNA cloning, microscopy, bacteriology, and protein work. She is also experienced with developing and optimizing client specific assays in line with industry regulations (GxP).

Jeffrey has been with Pfizer Kalamazoo for 18 years starting in R&D developing methods for trace metal analysis and process trouble shooting. Jeffrey has an extensive background in analytical chemistry developing new methods and applications.
Jeffrey is the chair of Pfizer’s Alternate & Rapid Micro Methods (ARMM) strategic committee responsible for the assessment, deployment, and support of rapid micro methods. Pfizer’s strategic ARMM goals are focused on automation of environmental monitoring and flexible manufacturing. Current projects include the development of automated online water bioburden analyzer, airborne bioburden, and automated colony counting systems.