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Ziva Abraham (CEO of Microrite)

Ziva Abraham

CEO of Microrite

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.

She has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

Aaron Allen (Director, Global Quality External Engagement of Moderna)

Aaron Allen

Director, Global Quality External Engagement of Moderna

Aaron Allen is an experienced Manufacturing Sciences and Technology professional with more than 25 years of process engineering, manufacturing and MS&T experience. Mr. Allen has transferred and executed process validation for multiple vaccines within Novartis and Moderna. He has recently transitioned to a new role as Global Quality External Engagement.

Mr. Allen’s previous experience includes positions with Diosynth, Biogen, Jacobs Engineering and Novartis Vaccines. Mr. Allen holds a bachelor’s degree in Chemical Engineering from the University of California at Santa Barbara.

Dr Edmund Ang (Senior Technical Expert, Asia Pacific, Bioreliance® Contract Testing Services at Merck KGaA)

Dr Edmund Ang

Senior Technical Expert, Asia Pacific, Bioreliance® Contract Testing Services at Merck KGaA

Edmund Ang, Ph.D., is a Senior Technical Expert and joined BioReliance® Contract Testing Services, Merck KGaA in 2017. Dr. Ang provides technical support on CMC testing of biotherapeutics to biopharma developers and manufacturers in Asia Pacific. He has more than 20 years of experience in life science industry with R&D experience in cancer drug and biomarker discovery at Eli Lily and Ionis Pharmaceuticals, as well as commercial technical experience in cellular analysis and bioproduction with Roche Diagnostics, Life Technologies/Thermo Fisher Scientific.

Edmund obtained his Ph.D. in Cell Biology from the University of Edinburgh and conducted his postdoctoral research on cell signalling at Stanford University and National Cancer Centre, Singapore.

Dieter Bachmann (Director, Aseptic Manufacturing of Johnson & Johnson MQ&SA)

Dieter Bachmann

Director, Aseptic Manufacturing of Johnson & Johnson MQ&SA

Dieter is the Director of Aseptic Processing at Johnson & Johnson's (J&J) corporate Sterility Assurance group with a main responsibility for providing standardization, science and education across J&J in the field of aseptic processing technologies. He is a pharmacist by training with 30+ years of experience and holds a PhD in Pharmaceutical Formulation Technologies. Dieter has worked in small family-owned companies as well as in global business organizations. Since joining J&J in 1998, he has held several positions in R&D, Operations and Quality of J&Js Pharma and Medical Device franchises.

Alongside business, Dieter also always engages in associations work. For 10 years, he worked as a Swiss national delegate on developing monographs for the European Pharmacopeia (EP) at EDQM in Strassburg. He is a frequent presenter and an active member of PDA and ISPE. Dieter engages at the German DIN/NA063 and ISO TC198. He has been the global convenor for ISO TC198/WG9 Aseptic Processing since 2019. Dieter is passionately engaged in improving Aseptic Training, and one of his recent projects is implementing Virtual Reality training for Aseptic Processing in J&J.

Manoj Bhargava (Partner, Capital Markets at Sidley Austin)

Manoj Bhargava

Partner, Capital Markets at Sidley Austin

Manoj Bhargava focuses his practice on international capital markets matters, with a focus on India and Southeast Asia. He has over 25 years of experience, with a particular focus on the life sciences industry; and has advised on more than 200 equity and debt capital markets offerings, helping raise over US$50 billion, for Indian companies.

Manoj has built a substantial practice advising clients on initial public offerings, follow-on offerings, and private placements, including U.S. Securities and Exchange Commission-registered offerings, SPAC transactions, and listings on the New York Stock Exchange, NASDAQ, and the stock exchanges of Mumbai, London, Singapore, and Luxembourg. Additionally, he has represented corporations, issuers, investment banks, and investors, and has advised on mergers and acquisitions, private equity investments, and dispositions. Manoj also has experience working on transactions in China, Australia, Europe, and the United States.

Manoj is consistently recognized by the India Business Law Journal as being amongst the top 100 international lawyers globally for India-related matters, in “The A-List” of India specialists 2019-2022.

Manoj’s significant experience includes: US$530 million IPO of Mankind Pharma; US$270 million IPO of Eris Lifesciences; US$260 million IPO of Vijaya Diagnostic Centre; and US$205 million IPO of Glenmark Life Sciences.

Richard Chai (Technical Service Manager at STERIS Life Sciences)

Richard Chai

Technical Service Manager at STERIS Life Sciences

Richard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.

Li Wei Chan (Microbiology Manager at MSD International GmbH (Singapore))

Li Wei Chan

Microbiology Manager at MSD International GmbH (Singapore)

Li Wei joined MSD International GmbH (Singapore) Biotech Sterile Fill- Finish site as the Microbiology Manager since Nov 2020. In this role, Li Wei is responsible for managing the EM program for aseptic cleanrooms & critical utilities, contamination control strategy for sterile final drug products and qualifications for new product introduction. He also ensures compliance to corporate and regulatory standards and supported regulatory inspections e.g. FDA PAI for Keytruda. In his previous roles, Li Wei was responsible for developing microbial control strategies, developing microbiological test methods, managing laboratory compliance and managed internal quality audits.

Li Wei received his Bachelor of Science (Biotechnology) from Monash University, certified Quality Auditor and had 16 years of experience in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities).

Yen Tong Chan (QC Team Leader at Roche)

Yen Tong Chan

QC Team Leader at Roche

Yen Tong has over 12 years of pharmaceutical industry experience in Microbiology, QA System and Validation and currently works as QC Team Leader in Roche Singapore. He was previously affiliated with MSD Singapore where he gained his first technical experience in supporting microbiological testing, thermal equipment validation, and cleaning monitoring program in Sterile Fill-Finish facility. After that, he was part of the startup team in Amgen Singapore, responsible for laboratory equipment qualification, method validation, utilities and environmental characterization. Yen Tong graduated with a BSc (Hons) in Microbiology and Biotechnology from University of Saskatchewan, Canada

ShiMing Chau (Quality Director of Janssen Pharmaceuticals)

ShiMing Chau

Quality Director of Janssen Pharmaceuticals

Shi Ming has over 27 years of experience in pharmaceutical industry. He is currently working for Janssen Pharmaceuticals (family of J&J) as Quality Director of Asia Pacific Supply to manage external suppliers ranging from vaccine, biologic and small volume parenteral drug products. Prior to joining Janssen ShiMing worked for Scinopharm Taiwan where he was the head of quality management overseeing the quality control, quality assurance and compliance functions for the company's facilities in Taiwan as well as in China. Prior to Schinopharm Taiwan, ShiMing spent over 16 years working for Schering-Plough Singapore then Merck (MSD) Singapore in the areas of quality control, quality assurance, technical services for technology transfer and cleaning validation as well as served and technical lead for regional business operation function for third party management in Asia Pacific region.

Shi Ming graduated from the University of Hong Kong with Ph.D in Chemistry and MBA from National University of Singapore.

Emily Cheah (Senior Managing Director of Charles River Laboratories)

Emily Cheah

Senior Managing Director of Charles River Laboratories

A pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.

She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.

Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013. Emily is the current President of PDA Singapore Chapter.

Scott Deckebach (Senior Director. Data Governance and Integrity Compliance of Lachman Consultant Services)

Scott Deckebach

Senior Director. Data Governance and Integrity Compliance of Lachman Consultant Services

Scott Deckebach is a Senior Director in the Compliance Practice at Lachman Consultants, Inc. He holds a M.B.A. from Michigan State University and a B.S. in Chemical Engineering from the Colorado School of Mines. Scott has 30+ years progressive pharmaceutical experience within multiple major companies including extensive manufacturing, information technology, compliance, lean/six-sigma and project management experience. Experience ranged from programming, validating and supporting many types of information systems to leading global teams charged with managing manufacturing and laboratory data and systems. Within Lachman Consultants Inc., he is responsible for driving and delivering data integrity and governance services to global clients including small and large molecule and medical devices.

Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

Richard Denk

Senior Consultant Aseptic Processing & Containment at Skan AG

Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

James Drinkwater (Head of GMP Compliance and Aseptic Processing Support at Franz Ziel)

James Drinkwater

Head of GMP Compliance and Aseptic Processing Support at Franz Ziel

James is the former Chairman and honorary member of the Pharmaceutical and Healthcare Sciences Society (PHSS), a not-for-profit educational platform for GxP. He also is the current leader of the PHSS special interest groups on Aseptic processing and Biocontamination. PHSS was one of the European Commission appointed commenting platforms in the Targeted Consultation process and he served as the co-lead of the focus group for Annex 1 revision and implementation. He also was the co-lead for PHSS’ focus group on Contamination Control Strategy (CCS) Guidance initiative.

In his capacity as the Head of GMP Compliance at Franz Ziel GmbH, James is actively involved on projects for Pharmaceutical, Biologics and ATMP product GMP manufacturing, specifically Fill & Finish projects. Based in the UK, James has a global support role and is also a qualified trainer on Aseptic processing with training collaborations through the University College London (UCL School of Pharmacy).

Huixing Feng (Senior Technical Expert APAC, BioReliance® Contract Testing Services at Merck KGaA)

Huixing Feng

Senior Technical Expert APAC, BioReliance® Contract Testing Services at Merck KGaA

Dr. Feng Huixing is the Technical Expert Asia Pacific in BioReliance Contract Testing Services, Merck KGaA. She provides biologics safety scientific and technical support and advice to biopharma developers and manufacturers in the Asia Pacific region. She has extensive life science and analytical instrument experiences in both academic and manufacturing settings. Huixing was previously a client facing Application Scientist at Agilent where she was responsible for the technical support for biopharma and life science markets.

Huixing received her Ph.D in Bioengineering in Nanyang Technologies University, Singapore.

Max Fernandez (Vice President at Intellective Bio)

Max Fernandez

Vice President at Intellective Bio

Dr. Max Fernandez is a regulatory, quality and compliance professional with over 20 years of experience and global leadership in biologics development, regulatory strategy, CMC, quality and compliance, manufacturing and tech transfer covering preclinical to commercial product lifecycle management.

Dr. Fernandez has been based in California for most of his career, making significant contributions to Baxter’s global efforts in the recombinant and plasma products space, and culminating in the US FDA licensure of VONVENDI, the first and only recombinant protein therapy for von Willebrand disease, in 2015. Before coming to China, he was the Head of Global Regulatory Affairs at Samsung Biologics in Korea, where he helped international and domestic clients obtain more than 100 approvals from major health authorities (US FDA, EMA, PMDA, Health Canada, ANVISA, Cofepris, etc.) for over 40 commercial products in 3 years. This remarkable success rate was enabled by over 20 on-site regulatory inspections with no critical observations. As Vice President of Intellective Bio, Dr. Fernandez is committed to helping one of China’s fastest-growing CDMOs meet global standards and making accessible advanced therapies for all.

Dr. Fernandez received his PhD in Analytical Chemistry from the University of California.

Rick Friedman (Virtual) (Deputy Director of US Food and Drug Administration)

Rick Friedman (Virtual)

Deputy Director of US Food and Drug Administration

Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

Selva G (General Manager - Pharma Services Group (PSG) at Thermo Fisher Biopharma Services Pte Ltd, Singapore)

Selva G

General Manager - Pharma Services Group (PSG) at Thermo Fisher Biopharma Services Pte Ltd, Singapore

Selva has been in the life sciences pharma bio industry for more than 25 years and holds a Bachelor’s degree in tech chemical engineering, a Master’s degree of business administration (MBA), and a diploma in GMP. He is an accomplished leader with experience in CDMO / CMO operations, manufacturing, P&L, large green field project delivery and site establishment, growth and business development, customer relationships, strategic alliances and partnerships, process and validation, and more. Throughout his career, he has collaborated with many global pharma bio organizations and provided various types of services and innovative solutions for the sectors such as biologics, vaccines, plasma proteins, active pharmaceutical ingredients (API), and cell and gene therapy.

Somasundaram G. (Senior Consultant at Merck Pty Ltd)

Somasundaram G.

Senior Consultant at Merck Pty Ltd

Somasundaram has been working closely with pharma & biopharmaceutical industry for 2 decades now. Som, is Senior Consultant for Asia Pacific in Merck Life Sciences under the Process Solutions division based in Singapore. He does consultation with customers in areas of Aseptic Processing, Quality Risk Management (QRM) and other BioPharmaceutical applications. He is also a Board member of PDA and ISPE industry associations, and works closely with the team in APAC.

Previously, Somasundaram was heading the Technology Management for South Asia & Oceania handling a team of Technology Managers who would work with customers in Product Adoption and training customers in best practices. Som has worked in different functions within Merck and Millipore in areas of Tech Service, BioReliance Validation Services, Commercial role and Business Development areas.

Somasundaram has post graduate degree in Food & Industrial Microbiology & Business Management.

Jay Jariwala (Senior Director, Regulatory Compliance of Sidley Austin)

Jay Jariwala

Senior Director, Regulatory Compliance of Sidley Austin

Jay Jariwala is the senior director of regulatory compliance with a focus on pharmaceutical quality system compliance and enforcement matters. Prior to joining Sidley, Jay served as team leader/Combination Products subject matter expert within the Office of Compliance at the Center for Drug Evaluation and Research (CDER), a branch of the U.S. Food and Drug Administration (FDA).

For over 13 years, Jay served as an FDA regulator at multiple FDA centers, including CDER, the Center for Devices and Radiological Health (CDRH), and the Office of the Commissioner, applying the agency’s laws, regulations, guidance, and other technical and administrative policies on drugs, medical devices, and combination products to policy development, facility inspections, compliance, enforcement, and approval processes. His FDA leadership experience includes serving as assistant country director (Drugs) and supervisory Consumer Safety officer in the agency’s India Office (New Delhi). Jay also participated as a subject matter expert in many drug inspections with a focus on data integrity and Out-of-Specification (OOS) investigations.

A noted speaker on a broad variety of topics including facility inspections, data integrity, OOS investigations, quality culture, supply chain integrity, corrective and preventive actions, and globalization and compliance trends, Jay also holds several medical device- and drug-related teaching roles. He earned a bachelor’s degree in Mechanical Engineering from the National Institute of Technology in Surat, India, and a master’s degree in Mechanical Engineering from Kansas State University.

Hue Kwon (Head of Quality at Samsung Bioepis)

Hue Kwon

Head of Quality at Samsung Bioepis

Dr. Hue Kwon has been serving as a Vice President and Quality Team Leader at Samsung Bioepis since April 2020. She leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.

Prior to joining Samsung Bioepis, she served as Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

Chee How Lee (Assistant Vice President, Healthcare at Economic Development Board)

Chee How Lee

Assistant Vice President, Healthcare at Economic Development Board

Chee How presently holds the post of Assistant Vice President, Healthcare. He is concurrently part of EDB’s Japan & Korea Desk.

Prior to his current role, Chee How served in EDB’s Medical Technology and Pharmaceuticals & Biotechnology industry sub-groups. He was most recently based in Tokyo, Japan as EDB’s Regional Director and First Secretary at the Embassy of the Republic of Singapore’s Office of the Counsellor (Industry), covering industries including Commercial & Professional Services, Consumer and Healthcare.

Chee How graduated from Hitotsubashi University in Tokyo, Japan with a Bachelor’s degree in Economics.

Wayne Lee (Fast Trak™ Validation Services Leader, Global at Cytiva)

Wayne Lee

Fast Trak™ Validation Services Leader, Global at Cytiva

Wayne has more than 23 years of combined experience in the pharmaceutical and biopharmaceutical, R&D, and manufacturing industry. He has broad experience in pharmaceutical synthetic chemistry unit operations, as well as biologics downstream processing.

He is currently the Global GM for Fast-TrakTM Validation Services, for Cytiva. Prior to his current role, he has spent more than 13 years in Pall Biotech; in roles of increasing responsibilities. His previous tenure includes Global Head of Validation and Laboratory Operations; Head of APAC (+China) technical support (MS&T); and BioProcess (MS&T) leader for ASEAN. Earlier, he has mixed experience from the Singapore Polytechnic, Merck Sharp & Dohme (Global Technical Operations); Galileo Pharmaceuticals and the Port of Singapore.

He was one of the founding board members of the PDA Singapore Chapter; current board member of the Singapore Chapter, previous board member of the UK Chapter and life-member of the Singapore National Institute of Chemistry (SNIC).

He is a seasoned practitioner of multiple Danaher Business system (DBS) tools; fluent in PSP, DM, SLXII, and is working towards Certified Practitioner (CP) for TPI, and is CP for VS 2.0. He holds a Ph.D. (Organic Chemistry; National University of Singapore) and an M.B.A. (Strategic and Operations Management; University of Bradford); and Double Bachelor’s Degree (Honors and Merit; Chemistry; National University of Singapore).

Pao Chun Lin (QC (ASAT) Manager at GSK)

Pao Chun Lin

QC (ASAT) Manager at GSK

Pao-Chun joined GSK Vaccine site (Singapore) as a Senior QC Specialist for Analytical Science and Technology team in 2020. She is the Project lead for the introduction of innovative technologies into the QC department in Singapore. Apart from equipment qualification and implementation, Pao-Chun is also responsible for bio-related analytical method validation and ensures compliance to regulatory standards. She is the QC Representative for inspection and has supported on-site regulatory inspections by HSA and EMA.

Pao Chun is an experienced scientist with a demonstrated history of working in biologics industry. Skilled in Stable cell line development, Glycosylation, In-vitro based assays, Monoclonal antibody production, Protein purification and analysis and Confocal Microscopy. She has a strong research background with a Doctor of Philosophy (Ph.D.) focused in Cellular and Molecular Biology from NUS (A-star scholarship).

Ivy Louis (Virtual) (Founder of Vienni Training & Consulting LLP)

Ivy Louis (Virtual)

Founder of Vienni Training & Consulting LLP

Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.

Ivy has been associated with PDA Inc.( from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board for PDA Inc.

Mohammad Ovais (Senior Manager,  Quality Technical Services at Sanofi)

Mohammad Ovais

Senior Manager, Quality Technical Services at Sanofi

Ovais has more than 18 years of experience working in pharmaceutical (both primary and secondary manufacturing) industry. Over the course of his career, he has worked with companies including Amgen, Abbvie, and GSK, in R&D, MSAT, validation, and quality assurance functions. His technical expertise covers many areas of pharmaceutical manufacturing including pharmaceutical development, quality assurance, quality risk management, validation, and technology transfer.

Currently, Ovais works as Senior Manager Quality Technical Services for Sanofi Manufacturing Pte Ltd. In his current role, he is working with cross functional teams to support Commissioning & Qualification, and technology transfer activities. Prior to joining Sanofi, Ovais worked as Principal QA Validation Specialist at GSK for about 3 years, where he provided quality oversight to validation activities and technology transfer; and served as subject-matter expert for cleaning and sterilization (including filtration) validation, and Extractables and Leachables.

Ovais is a participating member of ASTM International and has contributed to ASTM standards - E3016, E3263, G121, and G122. He is Honorary Auditor of PDA Singapore Chapter and is one of the co-authors of PDA’s Technical Report 29 (work in progress) on cleaning validation.

Ovais is a pharmacist by qualification and holds a master’s degree in Pharmacy from Hamdard University (India).

Dr. Priyabrata Pattnaik (Deputy Managing Director of Indian Immunologicals limited)

Dr. Priyabrata Pattnaik

Deputy Managing Director of Indian Immunologicals limited

Currently the Deputy Managing Director of Indian Immunologicals Limited, Dr. Priyabrata Pattnaik has more than 23 years of experience with increasing responsibility dealing with vaccine research & development, biologics operations, global vaccine initiative, applications support, process engineering, and business development.

He is co-author of 90 publications in international journals, eight book chapters and PDA Tech Report 89 on “Strategies for vaccine development life cycle management”.

Dr Pattnaik received a master’s degree in microbiology from Orissa University of Agriculture and Technology, India and PhD in Microbiology from National Dairy Research Institute, India.

Jim Polarine Jr. (Senior Technical Service Manager at Steris Corporation)

Jim Polarine Jr.

Senior Technical Service Manager at Steris Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty-three 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, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the prestigious PDA’s Scientific Advisory Board (SAB). He is active on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection and Technical Report #88 on Microbial Deviations. Mr. Polarine is on the PDA Technical Report #88 Planning Committee and TR #88 Workshop Presenter. 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 Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager 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.

Micheal Schafferius (Application Specialist for Separation Technologies at SARTORIUS)

Micheal Schafferius

Application Specialist for Separation Technologies at SARTORIUS

Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.

Yang Si (Head of Drug Product Manufacturing at Wuxi Biologics)

Yang Si

Head of Drug Product Manufacturing at Wuxi Biologics

Yang Si is head of drug product manufacturing of APAC MFG at WuXi Biologics, responsible for overseeing several sterile drug product facilities and a packaging center. With extensive knowledge in biologics and vaccines production, Yang specializes in sterile process design, technology transfer, validation, quality assurance, GMP pre-licensed/routine compliance inspections, and IND/NDA/BLA filings. Prior to his role at WuXi Biologics, Yang gained valuable experience at world-class facilities in Novartis and GSK. He holds an M.S. degree in Biochemical Engineering from Zhejiang University in China and is a certified PMP® by the American Project Management Institute.

Kim Sobien (Senior Consultant - Microbiology at Valsource)

Kim Sobien

Senior Consultant - Microbiology at Valsource

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.

Andiyanto Sutandar (Consulting Director of NNIT Singapore)

Andiyanto Sutandar

Consulting Director of NNIT Singapore

Andiyanto Sutandar is a Consulting Director at NNIT. Andi manages the consultancy operations of NNIT in Singapore where the Consulting team of over 40 consultants delivers business transformational solutions to the pharmaceutical industry through business process optimisation, industry best practice implementation and digitalization. Prior to his management role, Andi has delivered services in CQV, CSV, technology transfer, deviation and non-conformance management, supply chain optimization and project management. Additionally, Andi is an expert in high containment facilities for infectious diseases research.

Alex Tan (Senior Technical Services Specialist at Charles River Laboratories)

Alex Tan

Senior Technical Services Specialist at Charles River Laboratories

Alex Tan is a Senior Technical Services Specialist with Charles River Laboratories Singapore, specializing in endotoxin testing in various platforms. In his role, Alex supports the Technical Services for customers in the APAC region, he also drives the onboarding of new customers and is responsible for the initial training and validation/application support for customers as well as conducting method development and feasibility testing for the Endosafe® brand of products. His last position with the company was Team Lead, LAL and Microbiology testing, where he was responsible for protocol development and delivery of subcontract LAL and bioburden services. Alex has a degree in Molecular Biology and Biotechnology.

Samuel Tan (Head of Operations & Strategy at Novartis Singapore Pharmaceutical Mfg Pte Ltd)

Samuel Tan

Head of Operations & Strategy at Novartis Singapore Pharmaceutical Mfg Pte Ltd

Samuel is the Head of Operations & Strategy for Novartis biologics plant in Singapore. He has more than 13 years of experience working in biopharmaceutical industry (vaccines and monoclonal antibodies). He possesses the knowledge and excellent overview of how low bioburden and sterile manufacturing plant plans and operates, from receiving raw materials to producing the final sterile product.

Samuel graduated with a PhD in Bioengineering from the Nanyang Technological University, Singapore. He is currently the board member of PDA Singapore Chapter, leading the students and early career professionals subcommittee.

Edward Tidswell (Virtual) (Executive Director, Microbiological Quality and Sterility Assurance of Merck)

Edward Tidswell (Virtual)

Executive Director, Microbiological Quality and Sterility Assurance of Merck

Edward C. Tidswell, BSc, PhD - Dr. Tidswell is Executive Director within the Microbiological Quality and Sterility Assurance organization of Merck with ownership over sterility assurance and microbiology quality and compliance issues across all sterile and non-sterile products and manufacturing. His prior appointments include senior global R&D, and quality leadership roles across diverse drug, device and biologics portfolios for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing (ORCID: 0000-0003-0069-1967). Currently a member of the PDA Journal’s Editorial Board. Since June 2010 Dr. Tidswell is honored to serve and is currently Vice Chair on the USP’s Expert Committee for Microbiology.

Molly Ting (Director of Johnson & Johnson International (Singapore) Pte Ltd)

Molly Ting

Director of Johnson & Johnson International (Singapore) Pte Ltd

Molly Ting is the Director and Global Business Process Owner of Johnson & Johnson Pharmaceutical Segment Quality & Compliance Training. She is a microbiologist by training with more than twenty (20) years of experience in Medical Devices and Pharmaceuticals industry, experienced in analyzing complex operations processes and frameworks, identifying opportunities for improvement, and developing innovative strategies to achieve optimal organizational competencies for sustainable business performance. Molly is ACTA and ADKAR certified trainer and Change Management practitioner respectively, with strong cultural competence and is leading cross-cultural council and teams to drive sustainable changes across four (4) regions.

Rama Tummala (Principal Quality Audit Manager at GSK)

Rama Tummala

Principal Quality Audit Manager at GSK

Pharmacist by education, Rama Tummala has nearly 30 years of pharmaceutical industry experience in Operations, QA, Validations, Technology Transfer, MS&T, Quality and Compliance audits and Greenfield / Brownfield project management.

Rama is currently working with GSK as a Principal Quality Audit Manager operating from Singapore. Rama is conferred with 'GSK Fellow' and is part of GSK Fellowship of Scientific and Technical Excellence. He has previously worked in India with CIPLA LTD., The Himalaya Drug Company and Alcon Labs; in the USA and Singapore with Alcon Labs. He is also currently serving as a PDA Singapore Chapter core board member as Treasurer.

Mairym Williams (Director Quality Assurance of Amgen Singapore Site Operations)

Mairym Williams

Director Quality Assurance of Amgen Singapore Site Operations

Mairym Williams is the Director of Quality Assurance of Amgen Singapore Site Operations, home to Amgen’s first Next Generation Biomanufacturing and Commercial Chemical Synthesis manufacturing plants. In this capacity, Mairym leads the team that support the Singapore site manufacturing operations to ensure a compliant, reliable supply of high-quality drug substances to improve patient’s lives.

In her previous role as Director Quality, she led the Site Quality team of the Amgen Woburn Manufacturing (AWM) site, an oncolytic vaccine commercial manufacturing facility. Prior to this, Mairym was part of the Amgen Manufacturing Limited (AML) Quality Compliance team.

Mairym has over 29 years of experience in the pharmaceutical/biotech industry including compliance, quality assurance, manufacturing, project management, packaging and validation.

Anil Yadav (Global Account Manager, Industrial at Amazon Web Services)

Anil Yadav

Global Account Manager, Industrial at Amazon Web Services

Anil is leading Industry Next initiative at AWS with focus on industrial sector. In this capacity ; he is responsible for Go To Market Strategy and business development efforts across the region. He has 20+ years of experience helping enterprises in their business transformation journey across North America, Europe and Asia. He has held several leadership positions in ASEAN in the capacity of regional lead for industries such as Retail, Consumer Goods, Logistics and Manufacturing.