Experience

Crystal Formulation Services

• China
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Technology Officer

  • Jun 2022 - Present



Sage Therapeutics

• United States
• Biotechnology Research
• 400 - 500 Employee

• Director, Drug Product Technology

  • Sep 2018 - May 2022



Sunovion Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Formulation Development

  • Jul 2015 - Aug 2018

  Served as CMC leader, steering committee member; Managed cross-function groups within Sunovion, DSP and CRO for formulation and process development, clinical supply, and regulatory filing, etc. Served as CMC leader, steering committee member; Managed cross-function groups within Sunovion, DSP and CRO for formulation and process development, clinical supply, and regulatory filing, etc.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Specialist, Engineer

  • Sep 2011 - Jun 2015

  Managed cross-function groups within Merck and CRO for formulation and process development, technology transfer, regulatory filing, validation and commercial launching etc. Applied quality by design, design of experiments (DOE), statistical analysis and risk-based approaches for formulation and process development. Managed cross-function groups within Merck and CRO for formulation and process development, technology transfer, regulatory filing, validation and commercial launching etc. Applied quality by design, design of experiments (DOE), statistical analysis and risk-based approaches for formulation and process development.



Abbott

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

• Senior Research Scientist

  • Jun 2005 - Jul 2011

  Technical lead for several projects from phase I to phase III including formulation and process development, scale up, technology transfer, regulatory filing (IND/ IMPD/ NDA/sNDA) and PAI, including Simcor®. Technical lead for several projects from phase I to phase III including formulation and process development, scale up, technology transfer, regulatory filing (IND/ IMPD/ NDA/sNDA) and PAI, including Simcor®.



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Postdoc

  • Aug 2004 - Jun 2005

  Solid state characterization for lead API selection: polymorphs, hydrates/ solvates and amorphous API; Solide state characterization for formulation development: drug - excipients compatibility and crystallization inhibition. Solid state characterization for lead API selection: polymorphs, hydrates/ solvates and amorphous API; Solide state characterization for formulation development: drug - excipients compatibility and crystallization inhibition.