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Wednesday, March 20, 2013

Biocon Head - Insulin Manufacturing - HC/JC/2467/2013

Requirement Details
Requirement Head - Insulin Manufacturing - HC/JC/2467/2013
Job Category Production/Manufacturing/Engineering
Location Bangalore
Experience 10.00 to 15.00 years
Education M.Sc, Ph.D
Skills • Experience in Scale-up and manufacturing of Therapeutic Proteins on large scale is a must • Major part of experience should be in Purification than fermentation • Sound knowledge of cGMP and relevant knowledge on regulatory aspects is needed • Experience of facing USDFA and/ EU inspections is highly preferred
Industry Type Pharma/Biotech/Clinical Research
Posted On 07-Mar-2013
Job Description

·         Manage the entire fermentation and Purification operations of the Insulin bulk production facility at Bangalore
·         Lead the Scale up of Fermentation and downstream process from Pilot plant to the production facility by working closely with Development team
·         Facilitate transfer of process from Bangalore to Malaysia site in coordination with various functions

·         Balance commercial manufacturing with development activities
·         Train and mentor Key staff
·         Make Process Validation plan in line with Regulatory filing strategy and prepare the facility for Inspections from USFDA, EU and other regulatory authorities
·         Actively participate in making manufacturing strategy to support long term supply plan
·         Work closely with the supply chain management team to draw up monthly, quarterly and yearly production plans
·         Responsible for monitoring day-today operations towards the objective of continuously improving the performance metrics
·         Utilize prior knowledge on product costing and drivers in order to take timely measures so as to control manufacturing costs
·         Interact closely with R&D and Tech transfer teams to resolve process issues and scale up new processes
·         Pro-actively participate in tracking and improving the plant operations
·         Lead Operation excellence (OE) initiatives to improve efficiency of manufacturing operations
·         Guide OE team and Production team to drive cost reduction measures
·         Lead Process engineering (PE) team to successfully transfer processes from Pilot scale to the Production scale
·         Guide PE team and Production team to troubleshoot complex problems
·         Prepare annual budgets in line with annual forecast
·         Lead new initiatives and new process scale-ups 
·         Provide strategic directions in investigating deviations, out of trend and Out of specification to suggests a robust CAPA
·         Co-ordinate effectively across different functions to resolve a complex issue and drive new initiatives with concerted effort
·         Continuously monitor the implementation of cost reduction measures
·         Suggest usage of new technologies depending on latest industry updates and best practices
·         Periodically review progress with the internal group and senior management to assess  and evolve future strategy of the team

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