Experience

PharmaEssentia

• Taiwan
• Biotechnology Research
• 100 - 200 Employee

• Senior Scientist

  • Apr 2017 - Present

  Prepare technical reports/CMC to support BLA filing.Participate in pre-approval inspection (FDA)Develop control strategies for potential genotoxic impurities.Conduct external audits for material/supplier qualification.Provide internal training/audit for GMP compliance.Participation in management review and product quality review. Oversee outsourced activities and quality of purchased materials.Participate in EMA routine GMP inspection.Evaluate feasibility for new R&D project. Show less

• Scientist

  • Mar 2011 - Apr 2017

  Lead analytical method development and assist in analytical method validation.Lead impurity characterization and develop control strategy.Develop, implement, and modify pharmaceutical quality systems.Participate in pre-approval inspection (EMA) as subject matter expert.Conduct process optimization/characterization by a quality by design approach. Conduct process/cleaning validation through life cycle management.Establish and execute equipment/computer system qualification protocol.Establish and maintain operational standards for regulatory compliance.Ensure equipment is properly maintained and calibrated for intended use.Design and construction of a new GMP facility. Show less

• Associate Scientist

  • Mar 2007 - Mar 2011

  Experience in hundred kilo scale chemical production.Design around process patents of active ingredient.Prepare technical reports/CMC to support IND and DMF applications.Process development for small molecular drugs.Process development for chemical modification of polymer.Develop PEGylation process for long-acting PEGylated protein.Conduct raw material testing to assist GMP production.Develop and validate stability-indicating analytical methods.