Bachelor Degree or above with major in pharmacy or relative field.
More than 5 years of formulation development (oral solid dosage - ANDA) experience.
l Formulation development of solid dosage forms for Chinese market and US market.
Formulation development activities:
l Literature survey (chemistry, formulation, stability and bio related information on selected molecule for development), patent search and patent evaluation, regulatory guidelines interpretation.
l Familiar with QbD and DOE.
l Pre-formulation activities included drug-excipient compatibility, API and excipients characterization, innovator product characterization and reverse engineering.
l Lab scale development: planning and execution of lab scale trials. Operation of various equipment used for solid dosage forms like granulator, fluidized bed processor, drier, compression machine, coating, blister pkg etc.,
l Carry out necessary activities for the scale up and technology transfer of the product to manufacturing location for registration of dossiers and validations of the process.
l Support regulatory department for filing and approval process.
l Provide the data and report for filing.
l Regulatory queries response