PDA Singapore Chapter

Christina Chen
CAI

Christina is the Director of Operations at CAI (Southeast Asia). She has more than 20 years of C&Q and cGMP experience in equipment operation and validation of various equipment, manufacturing facilities, cleaning processes and process validation with various clients across Asia. Additionally, Christina has extensive experience in project planning, process design and is experienced with technology transfer from R&D to Bio Manufacturing equipment, and in conducting GMP compliance audits within Asia.

Christina obtained her Bachelor’s of Engineering from University of New South Wales.

Shi Ming Chau
Johnson & Johnson

Shi Ming has over 23 years of experience in pharmaceutical industry. He is director of External Quality for Janssen Supply Chain in Asia Pacific responsible for External manufacturers quality management in Asia Pacific countries like China, Korea, Taiwan and Japan etc. Prior to joining Janssen, Shi Ming is with 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, Shi Ming 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.

Lei Wei Chan
MSD International GmbH

Li Wei is a microbiologist with experience in cleanroom, utilities, product testing and microbial controls in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities). He is currently responsible for developing microbial control strategies, developing microbiological test methods, managing environmental monitoring program and managing laboratory compliance to corporate and pharmacopoeial standards. He also supports regulatory inspections e.g. FDA, PMDA, HSA, customer inspections, conduct internal inspections and managing QC audit program. Li Wei received his Bachelor of Science (Biotechnology) from Monash University, and is a certified GSK quality auditor.

Wayne Lee
Pall Biotech/Danaher

Wayne has more than 20 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. His previous tenure, was as, Head of APAC (+China) technical support (MS&T), for Pall Biotech. Previous experience includes roles of increasing responsibility in the Singapore Polytechnic, and Merck Sharp & Dohme. He was one of the founding board members of the PDA Singapore Chapter; member of the UK Chapter and life-member of the Singapore National Institute of Chemistry (SNIC). He holds a Ph.D (Organic Chemistry, N.U.S.) and an M.B.A. (Bradford), and was previously based at the UK Centre-of-Excellence, in Portsmouth; and is now based in Singapore, in the same capacity.

Somasundaram G (Som)
Merck

Somasundaram G (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 various other BioPharmaceutical applications area. Previously, Som was heading the Technology Management for Merck 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 for the last 20 years in Tech Service, BioReliance Filter Validation Lab, Commercial role and Business Development areas. Outside of Merck, Som worked for QA/QC for Pharmaceutical company & taught students Microbiology

Som has Master’s degree in Food & Industrial Microbiology & Master‘s Degree in Business Management.

Samuel Tan
Novartis

Samuel is the Head of Operations & Strategy for Novartis biologics plant in Singapore. He has more than 12 years 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 as result of the exposure working in various functions and companies.

Samuel graduated with a PhD in Bioengineering from the Nanyang Technological University, Singapore.

Prashanth Kumar Basika
Tessa Therapeutics

Prashanth holds Master’s Degree in Microbiology and is the QC Systems Manager at Tessa Therapeutics Ltd based in Singapore and responsible for QC Systems, Projects and Laboratory Equipment Qualifications. He has 16 years of experience in Quality Control, Quality Assurance & Validation roles in cGxP (ATMPs, Biologics, Nutritionals, Clinical & Beverage) industries. Prior to Tessa, he worked in various QC, QA, Validation, Quality Engineering Roles at PSC Biotech, CPR Pharma, Lonza Biologics, Genentech/Roche and Wyeth in Singapore. He has in-depth understanding of cGxP Systems which includes but not limited to GMP Facility Design/Cleanrooms, QC Operations, Quality Systems, CSV, Data Integrity, Commissioning and Qualification of FUE.

Kwong Toh Lum
West Pharmaceutical Service

Kwong Toh joined West Pharmaceutical Services in 2005 & is now the Regional Marketing Manager for Asia Pacific. Prior to joining West, he has over the years assumed roles in Business Development, Sales, Regulatory Affairs and Country Management in the pharmaceutical, medical device and equipment industries. He holds a Bachelor of Science (Hons) in Microbiology from the National University of Singapore and a Masters of Business (International Marketing) from the Curtin University.