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  • Jobs:Drug Formulation Development Scientists
  • Time:2019-01-18
  • Recruitment:Unlimited
  • Wages:Negotiable
  • Requirements:

    Education:

    Bachelor Degree or above with major in pharmacy or relative field.

    Working Experience:

    More than 5 years of formulation development (oral solid dosage - ANDA) experience.

    Technical:

    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

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