Experience

Onward Therapeutics

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• CMC Director (Consultant)

  • Jul 2020 - Present



PharmaEngine Inc

• Taiwan
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CMC Director

  • May 2007 - Jul 2020

  2007– Solved the manufacturing problems of our liposome product within 2 months when I was just on board and facing our clinical supply crisis. 2008 – Redesigned the production system from a lab-scale to a close system to comply with cGMP and passed the QP inspection of the EU. 2009 – Prepared the IND package of the CMC section and responded to US FDA’s comments to initiate a clinical trial in the USA. Got the company’s MVP. 2010 – In charge of China IND application submitted in 2006. Got the IND approval from SFDA in April of 2010 after three runs of communications. 2011 –In charge of the CMC responses from our licensee’s Due Diligence (DD). Successful license-out to Merrimack US and Got 220 million USD. 2013 –In charge of the PEP06 project, A new drug discovery (NCE) program collaborated with Guangzhou BeBetter. 2014 – Prepared and submitted the CMC questions for the pre-NDA meeting with TFDA and US FDA. 2015 –In charge of the CMC package for the NDA in TFDA and responding to the comments from TFDA. Got the NDA approval from TFDA & US FDA in Oct of the same year. 2016 – Performed a quality system audit for the CMOs (Merrimack & Sharp in the US) with our QA for the 1st launch of our new drug in Taiwan. 2017-2018 Performed DD to two licensers with our translational sciences VP for the new project evaluation. One in the USA and the other in France. Show less



UBI Asia ((聯亞生技)

• 台灣 Taiwan 新竹縣

• TD Associate Manager

  • Mar 2004 - May 2007

  Built up a technical department (TD), relevant SOPs, and the R&D lab at plant II of UBIA to develop four ANDA products including non-aqueous injectable suspension collaborated with our US agent. Prepared the CMC documents (Section 8~22) on our own for ANDA submission to US FDA in 2005. Except for developing our own ANDA products, we started to do a CDMO business for getting generic drug licenses in Taiwan for our clients since 2006. Such as 2006/06- Got a sterile injectable powder license for Anxo; 2006/08- Got the panadol diclofenac gel license for GSK and also developed a hot remedy, tablet, and solution of cold as well as spray of pain release for GSK. Show less



PURZER (瑞安大藥廠)

• 台灣 桃園市 觀音

• R&D Associate Manager

  • Jun 1996 - Mar 2004

  In the beginning, I was doing method development and troubleshooting for the old drug products. Two years later, I was assigned to do generic drug and some new technology development for the company. Before I left, I got a total of 13 generic drug licenses (2 injections, 4 eye drops, 6 oral solutions and one nasal spray of peptide) and 4 products (one nasal spray and 3 tablets) were submitted for getting TFDA approval. The others - Help to get the ISO9001 certificate for the company - Develop a new delivery system and get a multinational patent - Develop a scale-up technology for our topical use liposome product - Got the most contribution award of the company in 2002 Show less