Candidates for President Elect:
Mark R. Bogs
Mark Bogs is the Director of Sterility Assurance at ICU Medical and is responsible for supporting pharmaceutical moist heat terminal sterilization, and medical device Gamma, E-Beam and Ethylene Oxide sterilization and aseptic manufacturing across global ICU Medical sites and third party manufacturing. He has experience in start up aseptic filling operations, established aseptic filling operations for small volume parenterals and Blow Fill Seal, and Ethylene Oxide, Gamma and E-Beam radiation sterilization.
He has previously held Global Quality Director roles at Pfizer, Hospira, and Hollister and site QA/RA Director roles at Catalent Pharmaceutical, Dentsply Pharmaceutical, and LifeWatch. He has operations experience as the Manufacturing Manager at the start up of an aseptic pharmaceutical site at Dentsply Pharmaceutical and as the Plant Manager of an Ethylene Oxide sterilization plant for Sterigenics in the Chicagoland area. He began his pharmaceutical career at Abbott Laboratories Hospital Products Division as the Manufacturing QA Supervisor for the Small Volume Parenteral aseptic filling and finishing operation in North Chicago, IL.
Mark holds a BS in Chemistry from Purdue University and an MBA in International Business and Finance from Loyola University of Chicago.
Candidates for Treasurer:
Mr. willett is currently the Midwest Manager for Veltek Assoicates Inc., providing contamination control products and services to the pharmaceutical, biotech, and healthcare industries. In this position, Jason regularly consults with pharmaceutical manufacturers in the areas of cleaning, disinfection, aseptic practices, environmental monitoring and regulatory expectations. With over 20 years of relevant experience, Jason is able to help customers develop compliant and cost effective contamination control programs. In addition to his responsibilities at Veltek, Jason is a volunteer on the PDA's Exhibits Committee.
Jason graduated from the University of Cincinnati with a Bachelor's degree in Chemistry and lives near Cincinnati, OH with his wife Leslie, and three children, Ella, Laney and Matthew. Outside of work, Jason enjoys several sports and volunteers with his local youth sports organizations, Cub Scouts (Treasurer), church and children's school.
- PDA Member Since: 2008
- Current volunteer for PDA Exhibits Committee
Candidates for Secretary:
Eric Peryer is currently a Senior Manager, Research leading the Sterility Assurance team in Baxter’s Medication Delivery business unit. Current responsibilities include supporting terminal sterilization for new product development and changes to existing products across the globe as well as disinfectant efficacy and Global Pathogen Safety. The team is also responsible for the development of Sterility Assurance related content included in Regulatory submissions. Eric has over 20 years of experience in the pharmaceutical industry including formulation development, installation and validation of cleanroom and aseptic processing equipment and terminal sterilization of IV drug solution and medical devices. Eric has been with Baxter since 2006 and holds a B.S. degree in Chemical Engineering from Clarkson University in Potsdam, New York.
Candidates for Social Media Member:
Mr. Paddock has been with Baxter Healthcare since 2001 in the Sterility Assurance Organization (R&D and Quality), responsible for global operation support, relative to regulatory submissions/responses, process excursions, investigations, and product/process qualifications. Ken has over 20 years of sterilization experience in which he has provided facilities assistance in aseptic manufacturing and terminal sterilization methods such as moist heat, ethylene oxide and radiation.
He is an active member of PDA, holding local positions such as Midwest Chapter President and currently holds the Treasurer position of his local chapter. In addition, Ken is currently active with AAMI (Association for the Advancement of Medical Instrumentation). He received his Bachelor’s degree from Carthage College in Kenosha Wisconsin.
- PDA Member Since: 2003
- Current Committee Member for Annual PDA Aseptic Processing - Sterilization
Candidates for Member at Large:
Alan Solomon is an Engineering Specialist in the Research and Development organization of Baxter Healthcare. Currently responsibilities include leading the Medication Delivery Sterility Assurance Engineering group. He supports operations worldwide with new and modified sterile products from design to validation, qualification, submission and continuous manufacturing improvement. He is a Subject Matter Expert in sterilization engineering and utilizes Six Sigma methods to launch marketing leading and award winning innovations. Previously he designed moist heat autoclaves, liquid chemical sterilizers and biological indicators at STERIS corporation. He has over a decade and a half of experience and holds eight patents in the area of design and development of FDA regulated products. He obtained a Masters in Engineering Management from Case Western Reserve University, and a Bachelor’s in Biomedical Engineering from the University of Rochester. He is also a board member of the ISPE Sterile Products Processing Community of Practice. He has had diverse roles in PDA and PDA Midwest such as Treasurer and President.
- PDA Member Since: 2007
Bob Miseyka is President and a Managing Partner of Raland Compliance Partners, and directs the Life Sciences Compliance Division for the company.
Prior to merging with Raland in 2014, Bob was Managing Partner of Compliance Partners, LLC for twelve years. As a founder of Compliance Partners, Bob successfully built the company on a national and international basis. Bob has a 35 year history in Life Sciences support services, in particular for FDA regulated, technical and scientific disciplines. He previously owned an engineering technical services company as well as a financial services firm.
Bob is a graduate of the Edinboro University with a BA in Mathematics and additional post-graduate work at Gannon and Purdue Universities in Business and Industrial Management.
Bob Stringham is the Microbiology Manager of Sterility Assurance at ICU Medical and is responsible for supporting pharmaceutical moist heat terminal sterilization, and medical device Gamma, E-Beam and Ethylene Oxide sterilization and aseptic manufacturing across global ICU Medical sites and third party manufacturing. He has experience in aseptic filling, startup biotech, 503(B) compounding, and terminally sterilized pharmaceutical organizations with a strong focus on Environmental Monitoring.
He has previously held Manager roles at Pharmedium, Pfizer, and Hospira and a Supervisory role with GlaxoSmihKline. He has lead multiple Environmental Monitoring teams across varying industries, with an emphasis on compliance to evolving trends in industry. Bob began his career performing food microbiology testing with Silliker Laboratories in Chicago Heights, IL.
Deborah Gessell-Lee is a career Industrial and Pharmaceutical Microbiologist with a current role serving as a Senior Corporate Microbiology and Quality Advisor for CVS Health. Previous to this role, Deborah spent over 13 years as a Research and Development Scientist with Baxter Healthcare and STERIS Corporation. Within these roles, her efforts focused on various aspects related to infection prevention and microbial control of pharmaceuticals and medical devices. Most recently, Deborah served as the Adventitious Agents Subject Matter Expert for Baxter Healthcare, where she managed the Global Pathogen Safety Group and ensured regulatory compliance, supply chain quality assurance and manufacturing process assurance for all products derived from animal sources. Prior to this role within Baxter, she led the Alternative and Rapid Microbiological Methods Evaluation Program, conducting research in novel and emerging sterilization, as well as microbial monitoring and control technologies for the practical application to Baxter’s new and existing product portfolio. As a Senior Research Scientist at STERIS Corporation, Deborah aligned current products to gain market share in the sterilization field. Developments included the introduction of improved biological indicators, related production methods and low temperature sterilization technologies into the Hospital, Life Science and Government business sectors. Efforts contributed to the successful registration of an EPA-registered sterilant for area decontamination and an FDA cleared medical device for low temperature sterilization. Deborah’s interest in the safety aspects of pharmaceuticals and medical devices began when she earned her Doctorate in Microbiology and Immunology from the University of Texas Medical Branch, and concentrated in the study of pathogenic mechanisms of infectious diseases.
Jeff Pettet is a Consultant Scientist for sterilization validation for the Technical Services/Manufacturing Science (TS/MS) organization at Eli Lilly and Company. In this role, he is responsible for leading the sitewide Sterilization/Depyrogenation and Temperature Mapping programs at Eli Lilly’s Indianapolis Parenteral Manufacturing site. At Lilly, he also is an active Sterility Assurance Strategy Team member for the Indianapolis site focused on innovation, continuous improvement, and compliance. Jeff is active within Lilly’s multi-site network sterilization program leadership team focused on compliance, harmonization, innovation, and continuous improvement. Jeff’s leadership inside these focus areas provides continual consultant activities within the Lilly worldwide network.
Jeff joined Eli Lilly in 2014 as an operations associate for vial filling leading a cross functional process team. He was promoted to operations manager for oncolytic formulation/prep and freeze drying before transitioning into his current role with TS/MS. Prior to joining Lilly, Jeff served in many different aspects of parenteral manufacturing at increasing levels of responsibility within each focus area at CSL-Behring and EMD Millipore (now MilliporeSimga). These positions primarily focused within aseptic processing and include roles in operations, quality, technical services, logistics/warehouse management, global planning, operational excellence/six-sigma, and validation. In total, Jeff has 23 years of parenteral manufacturing experience. Jeff is a Six-sigma blackbelt with a degree in business administration-finance from Olivet Nazarene University.
- PDA Member Since: 2003
Peter Berzins is currently the Global Quality Advisor responsible for oversight and setting Global Quality Standards for Production Practices, Validation, and Sterility Assurance.
Mr. Berzins holds an undergraduate degree in Bio-medical Engineering from Marquette University in Milwaukee WI and an MBA from Meredith College in Raleigh NC. He has over 26 years of operational, engineering, and leadership experience in the US Navy and Pharmaceutical industry, including 20 years of Parenteral manufacturing experience. Mr. Berzins’ roles have included project and technical leadership of several parenteral manufacturing facility design, construction, commissioning and qualification, start up and regulatory approval projects. In addition, he has supported and led several parenteral and device manufacturing operations. Finally, he has implemented several education, training, qualification and career progression programs in engineering and operational roles.
Mr. Berzins has been an active member of the Parenteral Drug Association for nearly 20 years attending several PDA courses as well as national and chapter conferences and events.
- PDA Member Since: 2000
- Aseptic Processing Intrest Group
- Aging Facilities Interest Group
- Cell & Gene Therapy Interest Group
Pete is a microbiologist at Baxter Healthcare Corporation within the Sterility Assurance Community of Practice, specializing in the applications and evaluation of alternative and rapid microbiological methods, as well as supporting the Global Pathogen Safety role; he has previously supported the microbiological aspects of environmental monitoring, bioburden evaluation, and validation of sterilization processes. He has been a member of the Parenteral Drug Association since 1999, and served on the PDA Midwest board in various capacities from 2001 to 2015 (Member-at-Large, Secretary, President-Elect, President), and the PDA Chapter Council as Co-Chair from 2009 to 2011. Additionally, he has served on the committees for PDA Technical Report 13 “Fundamentals of an Environmental Monitoring Program” (rev 2014) and PDA Technical Report 69 “Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations” (2015). Outside of PDA, Pete is a member of the Online Water Bioburden Analyzer Workgroup (OWBA) and a member of the steering committee of the Process and Environmental Monitoring Methods Workgroup (PEMM).
- PDA Member Since: 1999
- Technical Report 13
- Technical Report 69
Rose LaRue-Slater is currently a board member at large for the Midwest PDA.
She works for Charles River, Microbial Solutions Division, as Global Key Account Manager responsible for Pfizer, Baxter, and BMS. In this role she works to closely align CRL strategy and plans with the needs and strategies of these accounts.
Rose previously held the position of Account Manager II at Charles River Laboratories, starting in 2016. Prior to joining CRL, she held the role of Medical Business Development Manager for Infinity Plastics & Assembly (medical injection molding). She spent over 12 years in the contract sterilization industry, initially as a Project Manager and later as Territory Account Manger for STERIS Isomedix Services, offering Gamma and E-beam radiation and Ethylene Oxide gas sterilization services to the Medical Device, Pharmaceutical, Food, and other industries.
Rose began her career in the lab, supporting EO sterilization at SteriPro Labs (fka Griffith Analytical Labs), and later held microbiological lab roles with Abbott Labs and The National Center for Food Safety and Technology (NCFST). She has a B.S. in Biology from the University of Illinois, Urbana-Champaign and an MBA from the University of Phoenix.
Most importantly, Rose is a mother to three boys, ages 12, 10, and 8. She is active in the PTA and spent 4 years as President. She enjoys a life full of cub scout events, baseball games, basketball games, camping, Ninja-warrior programs, and computer coding camps. She lives in Downers Grove with her husband, sons, and pets.
Scott Myers has more than 25 years of experience in the pharmaceutical industry in Operations, Quality and Development. As a Senior Managing Consultant at Tunnell Consulting, he is responsible for account management, project oversight and business development as well as consulting in diverse areas such as regulatory strategy, site decommissioning and laboratory productivity. Prior to this, Scott was Executive Director, Compliance and Quality Oversight at Boehringer Ingelheim. Scott was responsible for setting the site’s strategy for the interpretation, auditing and execution to global requirements as well as leading the Compliance and Environmental, Health & Safety (EHS) teams. He has had additional leadership roles in global product launch and analytical laboratories. He has published and presented on novel drug delivery systems, analytical methods and techniques. Scott received his BS Degree in Pharmacy from Philadelphia College of Pharmacy and Science in Philadelphia, Pennsylvania.
- PDA Member Since: 2013