Assistant Manager

4 weeks ago

India Biocon Full time

Department Details Role Summary BU Biosimilar Process Engineering Lead - Mammalian cell culture and downstream processing The Process Engineering lead will be responsible for technology transfer projects from bench pilot scale to manufacturing scale resolve facility and process fitment challenges during the scale up and regular manufacturing propose and manage the qualification and validation needs arising out of changes in facility and equipment The candidate should be proficient in process scale up factors from bench to commercial for Cell culture Chromatography ultrafiltration normal flow filtration and Nanofiltration operations Apart from these the candidate will also be responsible for facility and equipment related deviations investigations and proposing engineering solutions to mitigate operational risks during the manufacturing operations This will also involve qualification validation as required by various regulatory agencies Basic Qualifications Bachelor s degree in Chemical Engineering Biotechnology with minimum ten years of process engineering and project management experience in a manufacturing pharmaceutical or biotech environment Demonstrated ability and understanding on the development and execution of qualification protocols IQ OQ and PQ and other validation lifecycle documents Candidate should be proficient in the use of Trackwise MS Projects and SAP for organising and tracking the various projects and GMP documents Key Responsibilities BU Biosimilar Process Engineering Lead - Mammalian cell culture and downstream processing The Process Engineering lead will be responsible for technology transfer projects from bench pilot scale to manufacturing scale resolve facility and process fitment challenges during the scale up and regular manufacturing propose and manage the qualification and validation needs arising out of changes in facility and equipment The candidate should be proficient in process scale up factors from bench to commercial for Cell culture Chromatography ultrafiltration normal flow filtration and Nanofiltration operations Apart from these the candidate will also be responsible for facility and equipment related deviations investigations and proposing engineering solutions to mitigate operational risks during the manufacturing operations This will also involve qualification validation as required by various regulatory agencies Basic Qualifications Bachelor s degree in Chemical Engineering Biotechnology with minimum ten years of process engineering and project management experience in a manufacturing pharmaceutical or biotech environment Demonstrated ability and understanding on the development and execution of qualification protocols IQ OQ and PQ and other validation lifecycle documents Candidate should be proficient in the use of Trackwise MS Projects and SAP for organising and tracking the various projects and GMP documents Educational Qualifications Required Education Qualification B E Required Experience 10 - 14 years

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