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Jennifer Cheung
VP Global QA Operations at Gilead SciencesJennifer Cheung has over 30 years of quality, compliance, and regulatory experience in biotechnology, pharmaceutical, and cell and gene therapy manufacturing. Currently the Vice President of Global Quality Assurance Operations at Gilead Sciences, Jennifer leads a team of quality professionals to provide oversight for contract manufacturing and testing network globally and ensure supply of quality medicines to patients by championing GMP compliance sustainability and delivering on regulatory strategies for successful pipeline launch and market assess for all products. Prior to joining Gilead, Jennifer was the Chief Quality Officer at WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO). She led a global organization of professionals in quality assurance, quality control, regulatory affairs, analytical development, and contract testing services. Jennifer held various leadership positions in United States and Singapore, spent five years on a biologics parenteral manufacturing startup project and three years to expand the biologics drug substance site overseas. Jennifer has a BS degree in Microbiology and MS degree in Manufacturing Management.
Christy Eatmon
Global SME, Sterile Drug Products at Thermo Fisher ScientificChristy Eatmon supports the global Sales and Business Development teams in providing technical support, designing strategies and supporting new business opportunities for Thermo Fisher’s sterile manufacturing business. Christy has more than 15 years of experience in the pharmaceutical industry with an emphasis on process engineering, product development, aseptic manufacturing and filling. She has working knowledge of all phases from drug discovery to sterile product commercial manufacturing with expertise in small and large molecule sterile formulation. Previously, Christy supported the Greenville, North Carolina, site as a Senior Principal Scientist in the Pharmaceutical Development Services area.
HyongKwon Kwon
Product Specialist at biomerieux KoreaHyongwon Kwon earned his Bachelor of Microbioengineering in Degree from KonKuk University. He currently is a Product specialist in bioMérieux and was previously a QC Manager at Biocorp.
Grace Lee, Ph.D, MBA, CQA
Founder, Principal Consultant of Elevalue Consulting LLCDr. Grace Lee serves as the founder and principal consultant of Elevalue Consulting LLC. Her work focuses primarily on Cell and Gene Therapies and Biologics.
With advanced studies at Stanford University and UC Berkeley, Dr. Lee has had the opportunity to contribute to various sectors of the pharmaceutical industry.
Dr. Lee's professional journey includes various roles at Genentech and Kyverna Therapeutics, including head of analytical development, CMC leader, and project leader. These experiences have provided her with a broad perspective on biopharmaceutical development processes, which she strives to apply in her current consulting work. Additionally, her experience in quality auditing has provided valuable insights into CDMO and CRO operations.
Meekyung Lim
Director, Partnership & External Supply Large Molecule of Johnson & Johnson- How to Manage Tech Transfer & Quality Management Systems: A Johnson & Johnson Case Study
- Q&A
- Workshop
Mee Lim brings over 23 years of expertise in manufacturing science and technology, pharmaceutical site leadership, and managing Contract Manufacturing Organizations (CMOs) at Johnson & Johnson. She currently leads the Large Molecule Drug Substance CMOs and Supply Chain Licensing Alliances, focusing on ensuring product availability to meet customer demands, delivering top quality at the lowest total cost of ownership, and fostering innovation and collaboration through supplier integration and process improvements.
Previously, Mee served as General Manager, overseeing operations at a Johnson & Johnson pharmaceutical manufacturing facility. Her experience spans across new product introductions and pharmaceutical tech-transfer, having held multiple key roles within the Manufacturing Science and Technology function. Mee holds a Bachelor of Science in Chemical Engineering and an Executive Master of Business Administration (EMBA).
Michie (Mei Kuen) Ong
Executive Director, US Quality of WuXi Advanced TherapiesMichie leads a diverse team of quality professionals and is responsible for the quality system, operations, and compliance of WuXi Advanced Therapies’ Philadelphia site. The Philadelphia campus boasts over 400,000 ft2 of facilities and 800 employees dedicated to the development, testing, and clinical and commercial manufacturing of cell and gene therapies. Prior to joining WuXi Advanced Therapies, Michie spent 16 years in Genentech and Roche focused on quality assurance, quality systems, compliance audit, health authority inspection, and lean manufacturing in different geographies. Her track record includes proven success leading pre-licensure inspections (PLI), pre-approval inspections (PAI) and routine inspections. Michie earned a Bachelor of Science in Biotechnology from the University of Monash, Australia. After graduation, she spent four years as a Research Assistant in the laboratories at the Department of Toxicology in the National University of Singapore.
Sungjei Park
Sr. Marketing Manager at bioMérieux Industrial Applications
Gail Ward
EVP/CQO at Samsung Biologics- How to Manage Tech Transfer & Quality Management Systems: A Johnson & Johnson Case Study
- Q&A
- Workshop
Gail is an experienced executive in the biopharmaceutical industry, currently serving as EVP/CQO at Samsung Biologics. Earlier experience includes roles at Prokidney Corp, an autologous cell therapy company as VP of Clinical Supplies/Head of Quality, Celltrion as VP of Quality and Quality Support, leading efforts that resulted in significant biosimilar approvals, and AD of QA at Diosynth RTP, Biogen and Lederle-Praxis Biologics (now Pfizer). She has experience in Phase I-IV products and has been an independent consultant in the pharmaceutical and biologics sectors. Gail holds an AD in Computer Programming and AD in Education.