• Graduated of Pharm.D.
• Familiar with analytical, biochemical & biological techniques, including HPLC, Capillary electrophoresis, SDS-PAGE and Spectrophotometry is a plus.
• Familiarity with CTD writing principles & CMC development, is a plus.
• Scientific documentation & search skills.
• Passion & familiarity with pharmaceutical formulation development.
• Ability to effectively interface and collaborate with multi-discipline teams in a highly-paced analytical & formulation laboratory environment.
• Ability to complete assignments within project specific timelines.
• Fluency of writing English reports.
Requirements
• Perform analytical method development/validation to support formulation and process development of biological drug products.
• Conduct development and laboratory analysis such as product testing and stability studies which requires critical level of accuracy.
• Participate in development & characterization of new drug products.
• Perform formulation development studies of biologic drug products.
• Collect, write and review technical documents such as CTD & regulatory reports.
• Provide & collect technical input for biologics development CMC projects.
• Maintain/initiate strong collaboration with co-workers.