Experience

PharmaEngine Inc

• Taiwan
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• President & Chief Executive Officer

  • Jan 2021 - Present



Proteostasis Therapeutics, Inc. (PTI)

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President Of Product Development

  • Aug 2019 - 2020

  • Defined CMC strategies and planned CMC activities/budgets for different phases of pharmaceutical development from pre-clinical to NDA. • Selected and managed CROs and CMOs to meet development timelines and provide clinical supplies. • Worked with internal research team on selection of drug candidates for development. • Authorized and reviewed regulatory documents, including IND and IMPD, and provided responses to CMC regulatory inquiries. • Collaborated with clinical team to… Show more • Defined CMC strategies and planned CMC activities/budgets for different phases of pharmaceutical development from pre-clinical to NDA. • Selected and managed CROs and CMOs to meet development timelines and provide clinical supplies. • Worked with internal research team on selection of drug candidates for development. • Authorized and reviewed regulatory documents, including IND and IMPD, and provided responses to CMC regulatory inquiries. • Collaborated with clinical team to define overall drug development strategy and plan. • Closely managed and monitored budget execution with financial team.

• Senior Director, Formulation

  • Sep 2017 - Aug 2019



Microchips Biotech

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of Formulation Science

  • Jan 2016 - Sep 2017

  • Provided guidance on formulation design to achieve target release/PK profiles and its associated manufacturing process through theoretical understanding and modeling of PK materials properties, structure, process, performance, and their relationships. • Characterized and modeled Microchips device/drug combination to understand the drug release mechanism and stability risk. • Applied theoretical understanding of formulation performance to design in vitro and in vivo experiments… Show more • Provided guidance on formulation design to achieve target release/PK profiles and its associated manufacturing process through theoretical understanding and modeling of PK materials properties, structure, process, performance, and their relationships. • Characterized and modeled Microchips device/drug combination to understand the drug release mechanism and stability risk. • Applied theoretical understanding of formulation performance to design in vitro and in vivo experiments. Interpreted data to understand drug release mechanism and optimize formulation performance, stability, and associated manufacturing process. • Advanced product development towards commercialization Jointly with device engineers. • Worked with internal and external key stakeholders on regulatory interactions and filings. • Worked with the executive team to evaluate/generate ideas for new product concepts, assess feasibility, and establish product development strategy and milestones. • Played a key role in company growth and expansion as one of the scientific leaders in Microchips. Show less • Provided guidance on formulation design to achieve target release/PK profiles and its associated manufacturing process through theoretical understanding and modeling of PK materials properties, structure, process, performance, and their relationships. • Characterized and modeled Microchips device/drug combination to understand the drug release mechanism and stability risk. • Applied theoretical understanding of formulation performance to design in vitro and in vivo experiments… Show more • Provided guidance on formulation design to achieve target release/PK profiles and its associated manufacturing process through theoretical understanding and modeling of PK materials properties, structure, process, performance, and their relationships. • Characterized and modeled Microchips device/drug combination to understand the drug release mechanism and stability risk. • Applied theoretical understanding of formulation performance to design in vitro and in vivo experiments. Interpreted data to understand drug release mechanism and optimize formulation performance, stability, and associated manufacturing process. • Advanced product development towards commercialization Jointly with device engineers. • Worked with internal and external key stakeholders on regulatory interactions and filings. • Worked with the executive team to evaluate/generate ideas for new product concepts, assess feasibility, and establish product development strategy and milestones. • Played a key role in company growth and expansion as one of the scientific leaders in Microchips. Show less



Vertex Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Materials Discovery & Characterization

  • Feb 2015 - Dec 2015

  • Led research activities to understand and troubleshoot drug substances, intermediates and drug products, manufacturing processes, and interpret the relationships between materials properties and performances (such as stability and bioavailability) - through materials science approach & characterization and providing sound solutions to the business. • Managed cross-functional collaborations with Formulation Development, Analytical Development, Chemical Development, Technical Operation… Show more • Led research activities to understand and troubleshoot drug substances, intermediates and drug products, manufacturing processes, and interpret the relationships between materials properties and performances (such as stability and bioavailability) - through materials science approach & characterization and providing sound solutions to the business. • Managed cross-functional collaborations with Formulation Development, Analytical Development, Chemical Development, Technical Operation, Quality, and Regulatory. • Drafted and reviewed regulatory CMC documents of solid state characterization, method development & specification justification cross all development stages (pre-FIH to NDA), including three approved Vertex products (Incivek, Kalydeco and Orkambi). • Participate in CMC meetings with regulatory agencies and inspections. • Coordinated GMP solid-state analytical activities with CROs. • Led and managed scientists to develop formulations for challenging drug candidates for pre-clinical and FIH studies. • Led and managed scientists who were in-house solid state characterization experts for drug substances, intermediates, and drug products, including x-ray powder diffraction, thermal analysis, imaging, spectroscopy, crystallography, and other physical characterizations.

• Associate Director, Materials Discovery and Characterization

  • Sep 2011 - Feb 2015

• Senior Scientist, Materials Discovery and Characterization

  • Feb 2010 - Sep 2011

  • Recognized as in-house solid state characterization expert for drug substances, intermediates and drug product, including x-ray powder diffraction, thermal analysis, imaging, spectroscopy, and other physical characterizations. • Performed solid-state analytical method development, transfer, and validation. • Led problem-solving efforts for projects in different stages of development. • Provided solid-state analytical information in CMC sections for IND/CTA and NDA. • Facilitated… Show more • Recognized as in-house solid state characterization expert for drug substances, intermediates and drug product, including x-ray powder diffraction, thermal analysis, imaging, spectroscopy, and other physical characterizations. • Performed solid-state analytical method development, transfer, and validation. • Led problem-solving efforts for projects in different stages of development. • Provided solid-state analytical information in CMC sections for IND/CTA and NDA. • Facilitated cross-functional (Formulation Development, Analytical Development, Chemical Development, Technical Operation, and Quality) collaboration. • Coordinated solid-state analytical activities with CROs. • Led the solid-state analytical group and manage scientists.



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Scientist

  • Jun 2005 - Jan 2010

  ANALYTICAL SCIENCE - TRANSFORM PHARMACEUTICALS A Johnson & Johnson Company, Lexington, Massachusetts Senior Scientist (September 2008-January2010) Scientist (June 2005-September 2008) • Technical team leader of multidisciplinary team with formulation and analytical development responsibility in early phase pharmaceutical development. • Performed solid-state characterizations for drug substance and drug product, including thermal analysis… Show more ANALYTICAL SCIENCE - TRANSFORM PHARMACEUTICALS A Johnson & Johnson Company, Lexington, Massachusetts Senior Scientist (September 2008-January2010) Scientist (June 2005-September 2008) • Technical team leader of multidisciplinary team with formulation and analytical development responsibility in early phase pharmaceutical development. • Performed solid-state characterizations for drug substance and drug product, including thermal analysis, imaging, spectroscopy, and other physical characterizations. • Developed formulation design to enhance oral bioavailability, including animal PK study design. • Led problem solving efforts for early and late development projects. • Provided analytical and formulation information in CMC sections for IND/CTA. • Managed manufacturing GMP clinical drug product and scale-up. • Evaluated and purchased solid-state characterization instruments including SEM, Near-IR chemical imaging, mercury porosimetry, pycnometer, BET surface area analyzer and texture analyzer. • Mentored and managed junior scientists; worked closely with pre-clinical, clinical regulatory teams. • Explored opportunities for drug-device combinations and technologies for local drug delivery. Show less ANALYTICAL SCIENCE - TRANSFORM PHARMACEUTICALS A Johnson & Johnson Company, Lexington, Massachusetts Senior Scientist (September 2008-January2010) Scientist (June 2005-September 2008) • Technical team leader of multidisciplinary team with formulation and analytical development responsibility in early phase pharmaceutical development. • Performed solid-state characterizations for drug substance and drug product, including thermal analysis… Show more ANALYTICAL SCIENCE - TRANSFORM PHARMACEUTICALS A Johnson & Johnson Company, Lexington, Massachusetts Senior Scientist (September 2008-January2010) Scientist (June 2005-September 2008) • Technical team leader of multidisciplinary team with formulation and analytical development responsibility in early phase pharmaceutical development. • Performed solid-state characterizations for drug substance and drug product, including thermal analysis, imaging, spectroscopy, and other physical characterizations. • Developed formulation design to enhance oral bioavailability, including animal PK study design. • Led problem solving efforts for early and late development projects. • Provided analytical and formulation information in CMC sections for IND/CTA. • Managed manufacturing GMP clinical drug product and scale-up. • Evaluated and purchased solid-state characterization instruments including SEM, Near-IR chemical imaging, mercury porosimetry, pycnometer, BET surface area analyzer and texture analyzer. • Mentored and managed junior scientists; worked closely with pre-clinical, clinical regulatory teams. • Explored opportunities for drug-device combinations and technologies for local drug delivery. Show less



Massachusetts Institute of Technology

• United States
• Higher Education
• 700 & Above Employee

• Lecturer, Department of Materials Science and Engineering

  • Jan 2005 - Jun 2005

  Taught two core courses: Microstructural Evolution in Materials (Undergrad Level); and Kinetic Processes in Materials (Graduate Level)

• Research Assistant

  • Jun 2000 - Jan 2005

  Designed and conducted research plans. Wrote reports for funding sponsors.