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.
o To observe the lab demo batches in PE Lab / R & D and identify Critical requirements of the process and provide the same.
o To select the equipment's for scale up & discuss with R & D and Production and finalize it.
o To act as a tool between Production, QC, QA with R & D / PELAB to absorb the technology from Lab to Plant.
o To observe the initial scale up batches critically & debottleneck the problems faced in the Plant.
o To have a complete Material, energy balance & Effluent data for the scale up batch to have the complete information about the process.
o To prepare "Do's & don'ts "for the process and give it to Production for regular batches.
o To conduct HAZOP study and implement the suggestions.
o To Review the Batch Process Record and Sampling Plan prepared by Production
o To prepare the PFD, checklist for Documents submitted &To assist QA in preparing Validation protocol.
o To Plan for DMF validation batches in Plant and ensure that CGMP compliance is adhered while doing the DMF validation batches.
o To check the ML or aqueous layer for product carry over and try to recover the same by extraction or by distillation techniques.
o To ensure that Safety system is in position or intact in the Plant.
o 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.
o To design system for emergency venting and emergency handling.
2. Job specifications / pre-requisites:
(qualification, experience, any other specifications)
B.Tech / M.Tech - Chemical Engineering, with 3 - 8 years of experience in handling Scaleup.