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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Visual Inspection Forum

April 23-24, 2019, Washington, DC

  • Markus Lankers

    Markus Lankers, PhD

    MIBIC GmbH & Co KG

    Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.

    Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.

    He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the USA.  

  • Gerald Budd

    Gerald W. Budd

    Phoenix Imaging Ltd.

    Mr. Budd is the founder and President of Phoenix Imaging, Ltd. The company was founded in 1986 to investigate the capability of using machine vision technology to isolate imperfections in tubing vials. He has managed numerous research projects for the development of specialized illumination systems and image processing technologies used in the automation of inspection equipment. He has been exhaustively involved in the development of Standard Lighting Environments and Advanced Particle Detection / Measurement technologies for the past 20 years. He holds a B.S. degree from the Eastern Michigan University in Physics and Chemistry with a concentration in Optical Instrumentation. Mr. Budd holds multiple patents for advanced image processing techniques in Optical Shape Recognition, Instrumentation, Advanced Lighting Systems and Particle Measurement Technologies. His company currently manufactures over 15 models of Manual Inspection Booths (MIB’s) that are used worldwide. Phoenix Imaging is a leading supplier of Referee Level Particle Standards (RLPS™) seeded in vials, cartridges, syringes and IV bags for use in calibration of inspection equipment and the appraisal/qualification of human inspectors.

  • Andrea Cedrola

    Andrea Cedrola

    Patheon, part of Thermo Fisher Scientific Inc.

    Andrea Cedrola was born in 1967 in Oleggio, Italy. He graduated in Chemistry from “Università degli Studi di Milano” (Milan, Italy) with a Master Thesis in collaboration with the EU Joint Research Centre based in Ispra (VA).

    His work experience in the pharmaceutical industry started in 1997 in the area of Plant and Equipment Qualification. He has since then developed remarkable experience in the qualification steps (FAT, SAT, Commissioning, IQ, OQ, PQ) both in the sterile area (lyophilized and PFS) and on solid dosage form and packaging equipment, with major focus on autoclaves, freezers, climatic chambers, ovens, tunnels, filling and capping machines.

    In 2003 he joined the Equipment Validation department of Patheon, part of Thermo Fisher Scientific Inc. In this role, he focused on the the qualification of Cleanrooms Areas/Clean Air Device and on Visual Inspection Systems (AVI machine, OCV/OCR, linear and 2D barcode readers). Specifically, he has strong experience in the activities of defective units preparation, recipes fine tuning and qualification activities for lyophilized and liquid products (vials), syringes and cartridges.

  • Mary Lee Ciolkowski

    Mary Lee Ciolkowski, PhD

    Bausch + Lomb

    Mary Lee Ciolkowski has 20+ years of experience in materials characterization and technical elements of maintenance of business activities within the pharmaceutical industry beginning her career with the Upjohn Company in the early 1990s. She manages all laboratory activities to support forensics investigations applied to particulate and foreign matter for the pharmaceutical and medical device businesses at Bausch + Lomb. She received a Ph.D. in Analytical Chemistry from the University of North Carolina at Chapel Hill.

  • Nathan Cox

    Nathan Cox


    Mr Cox has been with Kymanox since 2016 and currently leads the Quality Engineering group, responsible for combination product development and compliance. In his previous role, he managed the Process Engineering group, in which he was responsible for overseeing the development and implementation of a Visual Inspection process of difficult to inspect parenterals across multiple manufacturing sites, including process and procedure development, equipment qualification, and process validation. Mr. Cox has a decade of experience within the life sciences industry predominantly in the process development and technical operations space. He holds a degree in Biomedical Engineering from North Carolina State University.

  • Jorge Delgado

    Jorge Delgado


    Mr. Delgado joined Amgen in 2004 as Senior Engineer responsible for the maintenance and the validated state of Fill & Finish manufacturing equipment. He then was transferred to the Process Development function as Principal Engineer in Drug Product, responsible for the implementation of a hybrid single use and stainless-steel product transfer system in an isolator based aseptic operation. In his current role as Senior Manager in Process Development, he leads a team which continually improves the inspection and packaging operations through innovation. Most recently, after a successful implementation of an automatic visual inspection line for protein-based products, the team have been testing the application of Deep Learning in the inspection of pre-filled syringes to further improve the process.

  • Amber Fradkin

    Amber H. Fradkin, PhD

    KBI Biopharma, Inc.

    Amber received her Ph.D. in Chemical Engineering within the Pharmaceutical Biotechnology Program with a specialization in the field of immunogenicity of therapeutic protein aggregates at the University of Colorado at Boulder. Amber also holds a Masters in Science from the University of Colorado at Boulder plus a Bachelors of Science from the Colorado School of Mines. Amber currently holds the position of Director at KBI Biopharma where she manages the Particle Characterization Core that specializes in analytical methods for quantifying, characterizing and identifying submicron, subvisible and visible particulates. Previously, at Amgen, Amber was a Scientist within the biomolecular structures and interactions group where she supported biophysical characterization of protein products with a specialty in subvisible particle characterization and identification. She managed subvisible particle characterization for all commercial and late stage clinical products and authored particle characterization sections of numerous regulatory filings. She has over 12 years of experience (8 years industry) with analytical method development and validation, formulation and stability strategy, and protein biophysical characterization. Prior to Amgen, Amber’s experiences include analytical and formulation development for Merck & Co. and collaborations with BaroFold, Inc. to employ high hydrostatic pressure to refold proteins and control subvisible particles.

  • Ian Jehring

    Ian T. Jehring

    Merck & Co., Inc.

    Ian Jehring graduated from Iowa State University with a bachelor’s degree in Chemical Engineering and a Master’s Degree in Biomedical Sciences. Ian has 5 years of experience in the pharmaceutical industry providing support for the production of sterile parenteral products. He has 3 years of experience with visual inspection, including automated incoming component checks and finished product inspection.

  • Nicola Mauriello

    Nicola Mauriello

    MSD international GmbH

    Nicola Mauriello graduated from University of Naples “Federico II” with a Master of Science in Chemistry and Pharmaceutical Technologies. Nicola has been with MSD since 2016 starting in the External Manufacturing Quality Assurance supporting, among others, batch release activities. He recently joined MSD Global Technologies Operation on 2017, becoming the technical responsible for two CMO taking all the relative liabilities; as for example manage projects, CMO-initiated changes, etc. Currently, Nicola is focusing in process validation, especially in the visual inspection step making him discover a growing interest in this area.

  • Soren Meyer

    Søren C. Meyer, M.Sc.

    InnoScan A/S

    Søren C Meyer holds a Master of Science in Opto-Mechanical Engineering, with specialty in gas lasers.

    He has worked 10 years in the graphical industry, designing machines for optical exposure of serigraphy printing screens and offset printing plates.

    Søren joined InnoScan in 2005 and have designed a substantial part of the mechanics in the current InnoScan High speed Inspection machines. Søren have designed many of the optical inspection stations used on the InnoScan Inspection Machines.

    Søren holds the position as Mechanical and Hardware Engineering Manager at InnoScan, and is responsible for all Mechanical, Optical and Hardware development activities on Inspection Machines at InnoScan. 

    InnoScan is located in Aarhus, Denmark.

    In 2013, InnoScan became a part of Stevanato Group, with headquarter near Venice, Italy.

  • R. Douglas Ross

    R. Douglas Ross, MD, MBA

    Doug’s medical career started in obstetrics/gynecology and maternal-fetal medicine. In 1999 he made a career transition to the pharmaceutical industry and became actively involved in the medical assessment of product quality deviations and their effects on patients.

  • Antonio Scatena

    Antonio J. Scatena

    Gateway Analytical

    Mr. Scatena has been with Gateway Analytical since 2010 and was responsible for helping establish their particulate identification laboratory. He has held the roles of scientist and laboratory manager, responsible for the day-to-day operations of the laboratory and the investigational testing for pharmaceutical clients. Today, Mr. Scatena oversees sales and business operations and works as a scientific liaison between pharmaceutical clients and the laboratory for particulate matter investigations.

  • Aaron Shirkey

    Aaron J. Shirkey

    Merck & Co., Inc.

    Aaron Shirkey graduated from the Virginia Polytechnic and State University with a bachelor's degree in Electrical Engineering. Aaron has more than 15 years of experience in the pharmaceutical industry including more than 10 years in the automation field and over 3 years focusing on the visual inspection processes for parenteral products. Currently, Aaron works in the Technical Operations department where he provides support for manufacturing filling operations which includes vision inspection.

  • Joseph Straub

    Joseph A. Straub

    Merck & Co., Inc.
    Joseph Straub graduated from the Pennsylvania State University with a bachelor's degree in Engineering Science and Mechanics. Joe has 25 years of experience in the pharmaceutical and semiconductor industries, including the last 12 years at Merck focusing on the visual inspection processes for parenteral products. Currently, Joe works in global technical operations where he provides support for vision inspection processes and primary packaging components to Merck’s manufacturing sites and partners around the world.
  • Jonas Hoeg Thygesen

    Jonas Hoeg Thygesen, PhD

    Novo Nordisk Pharmatech A/S

    Jonas Hoeg Thygesen has been with Novo Nordisk Pharmatech since 2012. He is area specialist in the Novo Nordisk Pharmatech Microanalysis Centre, a center of excellence in Novo Nordisk for particle identification and characterization. Here he works with microscopy, microanalytical techniques and develops new analytical methods for material identification and characterization. Among his areas of expertise are spectroscopy, microscopy and advanced data analysis (chemometrics). He holds a Ph.D. from University of Copenhagen within Process Analytical Technology (PAT).

  • James Veale

    Jim Veale, PhD

    LIGHTHOUSE Instruments

    Jim Veale is the founder and President of LIGHTHOUSE Instruments. He received his PhD in Physics from the University of Virginia. His research and business interests are in developing laser spectroscopic methods for unmet needs in the pharmaceutical industry. His current focus at Lighthouse is on developing laser headspace analysis systems for container closure integrity, process monitoring, and quality assurance of sterile pharmaceutical products.

  • Andres Velez

    Andrés Vélez

    Bristol-Myers Squibb, Manati PR

    Andrés Vélez earned a bachelor’s degree in Electronics Engineering Technology from the University of Puerto Rico and has 20 years of experience in the pharmaceutical industry. Currently works as Senior Inspection Technology Specialist for Bristol-Myers Squibb (BMS), Manatí PR, where he is primarily responsible for vision systems tuning, characterization and validation of automated visual inspection (AVI) machines. His technical expertise on vision systems has been crucial for the implementation and continuous improvements of automated visual inspection for different vial (3cc up to 50cc) and syringe (0.4mL to 1mL) product presentations. He has significantly contributed to the reduction of false rejects/ejects from syringe and vial automated visual inspection machines as part of BMS continuous monitoring and improvement program. Under his leadership, the BMS Manatí team received a Gold Award in the Quest 2018 Operational Excellence competition at Ponce, PR.

  • Hailin (Sheena) Wang

    Hailin (Sheena) Wang, PhD


    Dr. Sheena Hailin Wang is currently a chemistry reviewer in the office of new drug products (ONDP) in the Center for Drug Evaluation and Research (CDER), and has been with the agency since 2013. She has reviewed many submissions for injectable drug products including complex drug substances and products containing nanomaterials. Sheena has been involved in the guidance development for Inspection of Injectable Products for Visible Particulates Prior to joining FDA, Sheena worked at Novartis vaccine and Diagnostics where she was a formulation development scientist and process/product development lead with expertise in protein formulation and nanoemlusion preparation.

    Sheena trained in chemistry and received her Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill with focus on process engineering and particulate sciences.

    In addition, Sheena is a member of the Visible and Subvisible Particulate Matter Expert Committee of the United States of Pharmacopeia. 

  • Steven Wardell

    Steven Wardell

    ATS Automation

    With a Bachelor’s degree in Mathematics and Computer Science, I started my career 30 years ago at ATS programming controllers and equipment used in high precision assembly systems. Whether programming, integrating, or managing the integration of high accuracy positioning stages, vision systems or related controls and instrumentation, I've been part of an automation company that has expanded from a one man shop to a worldwide industry leader today. For the last 8 years, I have been directing the Imaging group at ATS. Our core team of vision engineers support all of our automation facilities worldwide and provide 100’s of custom machine vision solutions each year to the Life Sciences, Automotive, Energy and Consumer Goods manufacturing industries.

  • Jose Zanardi

    José M. Zanardi-Ocampo, PhD

    Bosch Packaging Technology

    Zanardi is Senior Manager at Bosch Packaging Technology, where he is responsible for vision inspection development and applications at the Center of Competence for Vision Technology, located in Japan. In this position he has been project manager for platform development of automated inspection machines, and also responsible for vision technology applications in customer projects.

    Before joining the Bosch Packaging division, Zanardi worked at Bosch Corporate Research where he was responsible for the Japanese branch of that unit.

    He has a doctoral degree in materials science, with specialty in spectroscopic characterization of defects in semiconductor materials.

  • Elisabeth Zybczynski

    Elizabeth Zybczynski

    Baxter Healthcare

    Elizabeth has been with Baxter for 10 years and held various roles in R&D, Quality, and Risk Management. Elizabeth is currently the Director of Production and Process Controls for Baxter’s Global Manufacturing Network and currently leads Baxter’s Global Visual Inspection Harmonization Program. Prior to joining Baxter, Elizabeth worked in the Oil & Gas, Aerospace, and Automotive Industries.