Title:  Manager - Production

Roles and Responsibilities

•                    The incumbent must have experienced working on microbial cell culture, recombinant antibody manufacturing from microbial expression systems.

•                    Should have experience in manufacturing on 1000L bioreactor and handling automated CIP, CIP and TFF systems.

•                    Experience on manufacturing of consistency and commercial scale up batches.

•                    Good knowledge of technology transfer from R&D scale to commercial plant manufacturing.

•                    Should be responsible for qualification of equipment’s and facility.

•                    Sound knowledge on GMP and working in close with cross functional departments for execution of manufacturing activities within specified timelines.

•                    Should lead, motivate and train the team in GMP and GLP specified areas. Well acquainted with regulatory guidelines ICH, USFDA and CDSCO.

•                    Should have strategic thinking, Problem solving and decision making.

•                    Sound Knowledge on QMS

•                    Able to implement process steps for cost and time saving.