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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Contamination Control Strategy Workshop

08-09 December 2021

  • Frederic Ayers

    Frederic Ayers

    Eli Lilly and Company
    Fred graduated with a B.A. degree in Biology from Franklin College of Indiana in 1999, while being a student-athlete and participation in the colleges Leadership Program. After graduating, he spent two years working in the contract manufacturing industries (pharmaceutical, food) and joined Eli Lilly and Company in 2001. Since joining Eli Lilly, Mr. Ayers has held various quality and technical positions from which he has helped advance Lilly's state of regulatory compliance. He is regarded as a Subject Matter Expert in Sterility Assurance for the company's Indianapolis Parenteral Manufacturing site. Fred has the responsibility of developing, implementing and continuous improvement for the site’s sterility assurance related strategies. Additionally, Fred has been a PDA Midwest Chapter Board Member since 2014 and is currently serving as the chapter’s President.
  • Biswarup Dasgupta

    Biswarup DasGupta, MS

    Sarepta Therapeutics

    Biswarup DasGupta (Bis) is a Quality and Compliance leader with over 20 years of experience in QA, QC including contamination control. Currently, Bis is working as a QA Director for Sarepta's Gene Therapy program since July 2019. Before Sarepta, Bis assumed different roles in Quality organization with increasing responsibilities at Sanofi, GSK Biologics, and Altana Pharma. In these roles, he has developed effective contamination control programs, lead successful CD verification, implemented phase-appropriate GMPs, provided strategic leadership, and built a culture of quality and continuous improvement. Bis has a Master in Microbiology and BS in Chemistry, Biology, and Microbiology.

    Bis has co-authored TR13-2 and currently co-leading the new TR on Contamination Control Strategy.

  • Cheryl Essex

    Cheryl E. Essex, MS

    Sanofi

    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.

  • Jeff Gaerke

    Jeff J. Gaerke, PE

    CAI

    Jeff Gaerke P.E. - With more than 32 years’ experience in biotech manufacturing, Jeff has worked as a process engineer in API manufacturing as well as formulation and filling. Serving as an engineering subject matter expert with a focus on cleaning and sterilization, Jeff has supported manufacturing sites worldwide in the design, start-up, optimization, and troubleshooting of cleaning and sterilization processes. In this role, Jeff gained significant practical experience working on root cause determination and resolution of a number of sterility related challenges. After participating in an early retirement offering from Eli Lilly and Company, Jeff is currently working as a Principal Consultant with CAI.

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    David McFarland

    GSK

    David McFarland is the Lead Mechanical Reliability Engineer in GMS ENG EHS Shared Service CX and Primary, GMS EHS/Engineering at GSK.

  • Patrick Nieuwenhuizen

    Patrick Nieuwenhuizen

    PharmaLex Ireland

    Director Senior Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose. Qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design / Upgrade and risk facilitator for Quality Risk Management.

  • 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 and is an adjunct professor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County. He was co-chair of the Task Force for the PDA 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 and quality control.