Head (R&D) (VP) API Generics
BlueGenes Research
Mumbai, IN
6d ago

Job Description

  • Plan, direct and execute the API research
  • Guide and mentor the development team to develop small molecule generic APIs
  • Integrate this process into the overall generic drug development strategy of the company
  • Develop and implement a successful strategy to deliver DMFs every year for FDA submission
  • Provide vision and guidance in preparing the overall R&D strategic plan
  • Create seamless partnerships with the other R&D heads and the heads of other core areas (Marketing, Sales, Finance, Production and Business Development)
  • Lead scientists to the highest level of scientific excellence and productivity in the creation of API synthetic processes
  • Manage, support and evaluate external strategic alliance partners
  • Seek partnerships to ensure maximum efficiencies and leading-edge scientific capabilities
  • Prioritize, allocate and focus resources to provide the most rapid, effective identification and development of API candidates
  • Identify and implement technologies to expedite the API process
  • Create and sustain a company culture with the highest ethical and scientific standards and teamwork to achieve R&D objectives
  • THE CANDIDATE :

  • Ph. D. in Pharmaceutics, Organic Chemistry or a related field with minimum 10 years of API development experience in pharmaceuticals (5 of those years in managing team)
  • MS in a similar discipline with 15 years of experience and 5 years in management
  • Experience in directing and managing the research activities to scheduled deadlines
  • Complete familiarity and knowledge of cGMP and GLP
  • Extensive understanding of the API development process as well as considerable
  • Demonstrated success in transferring R&D API processes into production
  • Demonstrated success in preparing and filing DMFs to the FDA
  • Individual with a proactive management style characterized by effective leadership, commitment, enthusiasm, communication and teamwork
  • Ability to collaborate successfully with both internal and external colleagues to achieve company objectives
  • Apply
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