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Committee & Speaker Biographies

Committee & Speaker Biographies

PDA Southern California Chapter - 4th Annual Full Day Aseptic Processing & Sterilization Symposium

November 7, 2019, Irvine, CA

  • Paul Andrea

    Paul Andrea

    TAF Consulting, LLC

    With over 25 years in BioPharma, Paul Andrea has experienced the significant development and transformation of the industry and specifically GMP Manufacturing.  

    Paul began his career at Genentech.  In his 18 years there, he acquired technical and process expertise in Seed Train Operations, Equipment Preparation, Facility Management, Scheduling, Process Development, Formulation and Fill/Finish.   He took opportunities in GMP Production Facilities in South San Francisco and Vacaville and the Fill/Finish Facility in Hillsboro, Oregon.  After departing from Genentech in 2012, Paul and his family moved to South Korea where he was part of the first expatriate hires for Samsung Biologics.  Paul led the Drug Product Organization from equipment qualification to Regulatory Approval.  He also hired and trained over 100 Korean University Graduates with virtually no experience in GMP Manufacturing and more specifically, Aseptic Operations.  His additional responsibilities included representing the Drug Product Department as the primary interface for the Business Development group, interacting with potential new clients, performing facility fit evaluation, facility design, new product introduction, and Quality and Compliance support for all components of Drug Product Manufacturing.  

    After departing Samsung Biologics in 2017, Paul started TAF Group LLC.  His focus is to ensure the Manufacturing of Parenteral Drugs is performed in a safe and compliant manner following Global Regulatory requirements.  Whether it is an audit of your Sterility Assurance Program, performing due diligence visits for potential CDMO selection, writing SOPs and protocols, or working side by side on the shop floor with the technical team, Paul will approach all activities with professionalism, enthusiasm, and a will do attitude so that all objectives are accomplished.   

  • David Crance

    Dave Crance

    Particle Measuring Systems (PMS)
    David Crance is the Life Sciences Sales Manager for Particle Measuring Systems and has been in the Life Sciences business for over 30 years. He has lectured for pharmaceutical societies and organizations throughout the USA and Asia on environmental monitoring systems and their cGMP regulations. He has been an Instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland for the last fourteen years. David has been involved in the design and implementation of almost 500 environmental monitoring systems. In his role as Life Sciences Sales Manager, he works with leading engineering firms and manufacturers in the designing of Environmental monitoring systems.
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    Christopher Fenton

    B. Braun Medical Inc.

    Process Engineer for 3 years at Jubilant HollisterStier CMO
    Tech transferred both aseptic and terminally sterilized products.

    Team Lead for 1 year at Gilead
    Supervising the formulation department

    Operations Manager for 3 years at Jubilant HollisterStier CMO where I was promoted to Sr. Manager
    Managed Weigh/Mix/Fill/Finish operations for both aseptic and terminally sterilized products

    Currently Manager II for 2 years at B|Braun Medical Inc.
    Responsible for managing operations for 4 departments including Main Plant Sterilization

  • Jessica Frantz

    Jessica Frantz

    Sartorius Stedim North America

    Jessica Frantz is the current Technology Expert for Sartorius Stedim Biotech's Aseptic Transfer Technologies.  In this position she focuses on Single-Use solutions for systems involving the movement of components and fluids into and out of aseptic manufacturing spaces. 

    Prior to this she was the Product Manager for Bosch Packaging Technology’s Single-Use Dosing Systems where she specialized in the development, qualification and validation of their disposable dosing technologies. Jessica has also worked as a Project Engineer for Eli Lilly, where she focused on the specification, purchase, installation, qualification & validation of aseptic filling equipment. 

    She received a Bachelor of Science in Chemical Engineering from Rose-Hulman Institute of Technology, assisted in authoring a section of the PDA Single-Use Guidance, has been a Board member and is a current active member of the BPSA and is an active member of ISPE.

  • Manjula Ghosh

    Manjula Ghosh

    Allergan

    Manjula Ghosh has 27 years of extensive expertise in all aspects of Microbiology and Aseptic Processing, Quality Assurance, Quality Engineering and Validation.
    She has designed highly successful and compliant Environmental Monitoring and Aseptic Process Simulation programs and implemented the validation plan for new clean rooms (ISO 5, 6 and 7), isolator systems and pharmaceutical water systems.

    Manjula is an expert in the validation of sterilization and depyrogenation processes, cleaning validation, computerized systems and new equipment.

    She is knowledgeable in all aspects of Microbiology method validation and compendial and regulatory requirements and guidance. 

    Manjula is a senior Quality leader skilled in Verification and Validation (V&V), Good Laboratory Practice (GLP), Change Control, Validation of new products/ processes, and end to end Life cycle management, Investigations, CAPAs, Change controls, risk assessments.

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    Betty Howard

    STERIS

    Ms. Howard has been with STERIS Applied Technologies for more than 17 years and manages/ provides education and scientific guidance to Customers and potential Customers on a global scale for all areas of radiation sterilization. She is a member of industry committees responsible for developing content and guidance in the industry (ex. AAMI Working Groups for Radiation Processing, Sterility Assurance Levels and Materials compatibility). Betty has over 30 years industry experience in healthcare/ diagnostics and pharmaceuticals product applications including Radiation Sterilization ( dose setting, project management, testing) Biotechnology Research, Applications Development and Technical Support related to medical devices, drug discovery, analytic instrumentation, microbiology, biochemistry, sterilization processes and materials compatibility including previous positions with Amersham/GE, PerkinElmer, Illinois Department of Public Health. She holds a BS and MS degree from the University of IL in Biological Sciences and an MBA in Marketing and General Business.

  • Carol Julich

    Carol Julich

    TSI, Inc.

    Carol Julich has been a member of the PDA since 2009, and in the contamination control business since 2004. Carol started at Biotest Diagnostics selling particle counters and air samplers. During her tenure at Biotest Diagnostics it got acquired by EMD Millipore were she continued to sell the full line of contamination control products. 
    In 2014 Carol joined TSI, Inc and is currently Senior Technical Sales Representative and continues to sell air samplers, particle counters and the BioTrak for real-time air sampling.

  • Edwin Martinez

    Edwin Martinez

    Baxter Healthcare, Inc.

    Edwin Martinez is a subject matter expert (SME) on automated systems, with more than 20 years of manufacturing operations experience; in the design, development, integration and support of various automated processes, in combination with his BS on Electrical Engineering with a concentration on automated controls, vision systems and mechatronic.

    The past 15 years, he has been working in the deployment of new technologies for companies as Hospira, Pfizer and Baxter; in which he has managed numerous projects at several worldwide locations for the deployment and qualification of new advance automated systems, applied to most of the phases of the manufacturing process; filling, sealing, inspection, serialization and packaging.

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    Mehron Mirian

    VTI Life Sciences

    Mehron (Ron) Mirian has more than 18 years of experience in the Life Science Industry.   Mehron, who holds a BS in Biology, has worked for companies such as Bio-Rad, BBRaun, Avid and Molecular Templates in the United States. Mehron currently is the Regional Southern California Manager at VTI Life Sciences.

  • Jim Polarine

    Jim N. Polarine, MA

    STERIS Corporation

    Mr. 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 and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

  • Brita Salzmann

    Brita Salzmann

    CRB

    Brita Salzmann, EIT is a Process Engineer at CRB with over three years of experience in the AEC industry. She provides clients with insight on how to better use resources to improve efficiency and works on a wide variety of projects, designing and optimizing biomanufacturing facilities. As she continues to build her resume with new and exciting projects, Brita has become passionate about delivering the next generation of medicine through Advanced Therapy Medicinal Products (ATMPs), which encompass gene therapy, somatic cell gene therapy and stem cell products. The current rise in cell and gene therapies has provided Brita the opportunity to showcase her ability to deliver value through creative design options. She keeps up-to-date on developments in biopharmaceutical engineering through ISPE, including being featured in PE Magazine. Brita has pursued a natural calling to be involved with Women in Pharma® through mentorship and events.

    Brita graduated from the University of Colorado at Boulder with a Bachelor of Science in Chemical & Biological Engineering and a minor in Business. Originally from Colorado, she enjoys all things outdoors from beach volleyball to backpacking.

  • Stacy Sutton

    Stacy Sutton

    Argonaut Manufacturing Services

    Stacy Sutton received her B.A in Animal Physiology from the University of California, San Diego (UCSD). Ms. Sutton has 20+ years of industry experience and has worked in the fields of research, medical device and biopharmaceuticals. 

    Ms. Sutton has experience working for both start-up and large multinational companies.  Her current position is Vice President of Quality and Regulatory Affairs at Argonaut Manufacturing Services in Carlsbad, California.  Prior to that she held various roles of increasing responsibility through her tenure at Ajinomoto Bio-Pharma Services.  During her career she has headed several cross-functional teams for establishment of new capabilities, including processes, facilities and equipment to meet market demands.  All of her career has been spent in contract testing or contract manufacturing services.  

    Ms. Sutton is a member of both the PDA and ISPE for over 12 years.  She has previously served on the Board of Directors for the San Diego chapter of ISPE.

  • Peters Walters

    Peter Walters

    CRB

    Peter Walters is a lead process engineer at CRB, specializing in biological process and facility design.  He oversees conceptual and detailed design, multi-discipline coordination, and generation of design deliverables including conceptual floorplans and facility arrangement drawings, design narratives, P&IDs, material and energy balances, process simulations, cost analysis and specialized reports.

    Over the last 15 years working in pharmaceutical process and equipment design, he has gained a unique purview into aseptic equipment design, process scale up, pilot and manufacturing operations. His expertise includes experimental design, process characterization, equipment and process troubleshooting, and manufacturing for clinical Phase 1 through commercial production. He is well versed in cGMP manufacturing, including generation of procedures and batch records, validation of systems and processes, production performance and process and product analysis. He has designed process facilities for monoclonal antibodies, gene therapies, cell therapies, aseptic novel processes, both in stainless steel and single-use.  He helped author an NDA, has participated in FDA facility inspections, and is a patent awarded co-inventor of a novel process formulation method. Peter was recognized by Consulting – Specifying Engineer with the 40 Under 40 award in 2018. He is an industry contributor, and has previously spoken at ISPE, INTERPHEX, BPI West conferences as well as various online webinars.

    Peter graduated from University of California, Davis with a degree in chemical / biochemical engineering. He is a Southern California native and enjoys playing soccer and spending time with his family.