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Manager- DS Manufacturing (Mammalian)

Manager- DS Manufacturing (Mammalian)

15 - 18 years

|

14 - 20 Lacs

Posted:3 weeks ago| Platform:

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Skills Required

downstream biosimilars continuous process monitoring qms upstream mammalian cell culture cell culture drug subs manufacturing ds

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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