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Team Lead - Pre Sales
Team Lead - Pre SalesSai Life Sciences Ltd • Delhi, India
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Team Lead - Pre Sales

Team Lead - Pre Sales

Sai Life Sciences Ltd • Delhi, India
5 days ago
Job description
  • Handle end to end scale up activities from Lab to Pilot to Commercial Scale .
  • Absorb the process from the PELAB / R & D and study the same and come out with queries considering the plant constraints and ask to modify the same if not feasible in the Plant.
  • To observe the lab demo batches in PE Lab / R & D and identify Critical requirements of the process and provide the same.
  • To select the equipment’s for scale up & discuss with R & D and Production and finalize it.
  • To act as a tool between Production, QC, QA with R & D / PELAB to absorb the technology from Lab to Plant.
  • To observe the initial scale up batches critically & debottleneck the problems faced in the Plant.
  • To have a complete Material, energy balance & Effluent data for the scale up batch to have the complete information about the process.
  • To prepare “Do’s & don’ts “for the process and give it to Production for regular batches.
  • To conduct HAZOP study and implement the suggestions.
  • To Review the Batch Process Record and Sampling Plan prepared by Production
  • To prepare the PFD, checklist for Documents submitted &To assist QA in preparing Validation protocol.
  • To Plan for DMF validation batches in Plant and ensure that CGMP compliance is adhered while doing the DMF validation batches.
  • To check the ML or aqueous layer for product carry over and try to recover the same by extraction or by distillation techniques.
  • To ensure that Safety system is in position or intact in the Plant.
  • To impart training to Shift in charges, Chemists & subordinates about the process criticality and how to keep them in control especially in case of exothermic reactions.
  • To design system for emergency venting and emergency handling.
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