Downstream Process Assistant Manager

Position.
Assistant ManagerDSP (Manufacturing).
Required Experience.
Tech/M.
The role.
Process Development, scale up and manufacturing of proteins.
Downstream Processing of in house and contract research projects.
Preparation of SOP and validation protocols for downstream process.
Purification of different Recombinant Proteins.
Plan daily downstream execution activities.
Planning of raw material /consumables management for production campaign.
Drive the qualification activities for all downstream equipments.
Follow cGMP practices during the manufacturing activity and operations associated activities with QA and QC.
Compliance to cGMP in all the manufacturing activity, and timely closure of executed documents and batch records.
Active trouble shooting to minimize the various risks prior to execution and during execution.
Required Skills.
Knowledge in handling and troubleshooting purification chromatography systems & columns at small scale and large scale.
Various Chromatography techniques like Ion exchange, Affinity, HIC etc Ultrafiltration TFF (Hollow Fiber/cassettes).
Should be well versed with FPLC, AKTAProcess, AKTAPilot.
Capabilities for linear scalability of R&D process to Mfg.
scale.
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