Founder, President & CEO
Dr. Liu has 30 years of product, process development and manufacturing experience in biotech, pharmaceutical and specialty chemical industries. Prior to returning to Taiwan to start up EirGenix, Dr. Liu was the President and COO of AnGes Inc., a biotech enterprise in its late developmental stage.
Managing Director of EirGenix Europe GmbH
Dr. Thomas Schulze`s scope of experience covers numerous areas in pharmaceutical R&D and biotechnology, including biological and small molecule drug discovery and development, molecular diagnostics and product authentication.
Vice President, Chief Operating Officer (COO)
Dr Chih-Jung Chang is an Organic Chemist and has majored on the pharmaceutical field for nearly 20 years. He once worked as the director of TOT Oncology Business Unit at TTY Biopharm. During which, his main responsibilities included project management creating business and drug development strategies for licensing and collaboration in global NCE (Specialty)/Biologics (NBE/Biosimilars) projects.
Vice President, Chief Financial Officer (CFO)
Ms. Yang has more than 20 years of experiences in FMCG (Fast Moving Customer Goods) and medical industries. Prior to joining EirGenix, she has been responsible for accounting, finance, HR, administration, and IT departments and also has vast experience in the management and operation of the medical provider channel. Ms. Yang was a General Manager of ERS, which is a JV company between Fresenius and Excelsior, overseeing the management and operations of 100+ kidney dialysis centers in Taiwan. Ms. Yang holds a Master of Science in Accounting from University of New Haven in Connecticut (U.S.).
Executive Director, Chief Manufacturing Officer
Dr. Shang-Chung Ju has been working in the biotechnology area since 1989 after he earned his Ph.D. degree from National Taiwan University. His experience has been in the areas of bioprocess development, process transfer, and GMP manufacturing in biopharmaceutical pilot plant facility in DCB (Development Center for Biotechnology), Taiwan.
Executive Director, Analytical Science & Quality Control
Dr. Irene, Ae-Ning Lin, a Ph. D. graduate from University of Maryland, College Park, and Post-doc at University of Wisconsin, Madison, has been working in biotechnology field since 1987. She backed to Taiwan and works in the Process Development Division at Development Center for Biotechnology from 1987-2013. She has over thirty years of experience in purification process development, including therapeutic protein, plasmid DNA, bacterial and viral vaccine, enzyme and antibodies. She also has experience for the set-up and operation/validation of biological CGMP pilot plant for the production of phase I/II mammalian derived biologics. Since 2008 Dr. Lin is the Head of Process R & D Department of CGMP pilot plant in Development Center for Biotechnology as well as the co-project director of protein characterization program for the set-up of LC/MS analytical method for protein structure characterization.
Executive Director, Quality System
Dr. Ren-Yo Forng joined EirGenix in July, 2021 as the Executive Director of Quality System/Quality Assurance. Prior to coming back to Taiwan, he held the position of Scientific Director of Microbiology and Aseptic Manufacturing in Process Development of Amgen supporting all Operation sites of the Amgen network.
Executive Director, Manufacturing & Techinical Operation
Hark Chen, Executive Director is responsible in Manufacturing Technology Operation Division. Hark was the co-founder of Mycenax Biotech Inc. in 2001. During her days in Mycenax from 2001 to June, 2019, she took the responsibility in establishing two mammalian, one microbial and one fill-finish production lines, served as the director of GMP facility and deputy general manager of the process development department. She has accumulated 20 years of professional experience in the field of GMP factory management and production process development in the biopharmaceutical industry and participated in the development of several biological products from bionovels, biosimilars, glycan-protein conjugate, monoclonal antibody, and immune cell conjugate. She led her team to accomplish lots pioneer tasks including 1) perfusion operation in mammalian cell production in 200L single-use wave bioreactor process in 2004, 2) a new biological product for rheumatoid arthritis from cell line development to commercialization from 2004 to 2018, 3) the first monoclonal antibody produced in 2000L single-use stirred mammalian cell bioreactor in Asia in 2014, 4) a full-line continuous process development applied in a biosimilar product for phase I use, and 5) a monoclonal antibody conjugated with immune cells in a 200 L production scale. Hark Chen got her master degree in chemical engineering in National Taiwan University of Science and Technology Institute.
Executive Director, Regulatory Affairs
Dr. Ywan-Feng Li has 20 years of experience in the evaluation and regulation of biologics and biotechnological products. Dr. Li is in charge of the regulatory affair department since joining Eirgenix in 2022.
In 1999-2001, she worked as a research associate fellow in Depart. OB/GYN at the Veterans General Hospital-Taipei, where she focused on the studies of metastasis-related markers and Ab for radio-immunodetection of tumors. In 2001-2017, she worked as the CMC reviewer and then director of the Pharmaceutical Science Division at the Center for Drug evaluation-Taiwan (CDE). During 15-year stay in the regulatory agency, she established expertise in the evaluation and regulation of biologics/biotechnological products. In 2017, she transferred career to the biotech industry and served as the vice president of Medical & Clinical Center of the UnitedBioPharma Inc. with a role in oversee and management of the clinical development of several mAb products.
Dr. Li graduated from University of North Carolina at Chapel Hill followed by post-doc research at Fred Hutchinson Cancer Research Center, USA, and National Yang-Ming University, Taiwan.
Executive Director, Clinical Development & Operations and Medical Affairs
Dr. Barbara Grohmann-Izay has studied medicine, psychology and biostatistics in Vienna, Austria, and expanded her knowledge with attending a postgraduate program of clinical research.
In over 20 years of experience in industrial drug development and academic research, she worked within multiple therapeutic areas like oncology, vaccines(prophylactic and therapeutic), hematology, transplantation, cardio-vascular, inflammatory and metabolic diseases.
At EirGenix, Dr. Grohmann-Izay is leading the clinical development and operations team, currently working on the broad pipeline of mainly biosimilars at different clinical development stages.