Project Management

  • Assist in the Selection of special service providers

  • Project fundamentals, progress monitoring & reporting

    Budget; schedule; process engineering; quality assurance; quality control

  • Ensure alignment with functional unit & regulatory issues

  • Oversee the development of a concise program

    • Required manufacturing space • Equipment list • Process flow & utilities • Volume of production • Human resources

  • Factor budgets, cash flow and timelines

  • Development of operations criteria, manufacturing, & throughput goals

  • Identify technology

    Identify the appropriate technology to meet strategies and objectives

  • Review and approval

    Ensure appropriate review and approval which occurs before implementation of the technology

  • Establish site

    After selection criteria is implemented

  • Oversee the development of a validation master plan

  • Development of a concise program

  • Mini pilot that enables scale-up

  • R&D for new innovative and Biosimilars products

  • Training personnel for a smooth technology transfer

  • Continued support for ongoing projects

  • Preparation of required documentation

  • Ensure requirements are met

  • Lead or assist with Factory Acceptance Testing

  • Development, execution and/or oversight

    Assist in the development, execution and/or oversight of all installation, operation, and process qualification documents and activities