Manager- DS Manufacturing

2 days ago


Pune, Maharashtra, India Enzene Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per year

Role & responsibilities

  • Drive the successful delivery of the production plan for mammalian Drug Substance (DS) manufacturing in alignment with organizational goals.
  • Take full ownership of end-to-end Cell Culture processes, ensuring adherence to operational excellence and performance KPIs.
  • Lead, mentor, and develop the Cell Culture operations team, fostering high performance, technical competency, and continuous improvement.
  • Maintain effective financial control over all operational expenses related to mammalian DS manufacturing, ensuring budget compliance and cost efficiency.
  • Ensure robust Continuous Process Monitoring (CPM) of validated processes, analyze trends, and drive process optimization and improvement initiatives.
  • Perform and support root cause investigations for process deviations, OOTs, CAPAs, and operational issues, ensuring timely closure and preventive measures.
  • Proactively identify and evaluate technical challenges in Upstream or Downstream operations and provide effective solutions.
  • Collaborate efficiently with cross-functional teams including R&D, MSAT, QA, QC, Supply Chain, and Regulatory Affairs to ensure seamless coordination and compliance.


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