Pre-Sales Scale-Up ManagerSai Life Sciences Ltd • Hyderabad, Republic Of India, IN

Pre-Sales Scale-Up Manager

Sai Life Sciences Ltd • Hyderabad, Republic Of India, IN

17 hours 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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Manager • Hyderabad, Republic Of India, IN

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