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Assist. Director/ Director - Upstream Operations

15.00 to 24.00 Years   Indore   20 May, 2021
Job LocationIndore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and Responsibilities : The incumbent will bring in expertise with respect to validation, microbial fermentation, and technology transfer, scale-up of manufacturing operations and cGMP and regulatory requirements.

  • Leads develop and mentor the upstream purification team.Long and short-term strategic plan for upstream processing in collaboration with downstream manufacturing team to ensure uninterrupted operations.
  • Manufacturing of Exhibit batches for Regulatory approvals for India and US FDA.
  • Preparation of OPEX budget for upstream process.
  • Risk Identification, Risk assessment and Risk mitigation plan of upstream process.
  • Bring expertise and knowledge of fermentation manufacturing processes.
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Keyskills :
environmental impact assessmentcontinuous improvement facilitationrisk assessmentrisk mitigationtechnology transferupstream processingregulatory approvalsmanufacturing operationsriskcgmpopexstrategyupstreamapprovalsoperationsregulatoryvali

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