Senior Scientist

Role & responsibilities Strategizing the Biosimilar process development based on CHO & other mammalian cells lines for developing non-infringing Upstream process. Understanding the cell Lines, cell culture & Bioreactor process based biotherapeutic proteins development towards submission in India & various regulated countries. Good knowledge of Cell line development & cell line characterization. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Designing and conducting the process characterization for upstream development Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analyzing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. Capable of leading a team of Scientist & Sr. Scientist for day-to-day Cell culture works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Oversee and coordinate work performance at Production plant or any 3rd party Manufacturing unit Support to commercialization activities (assistance for tech transfer, process validation studies, manufacturing investigation, trend evaluation & troubleshooting) Literature survey, Patents identification & writing research papers Preparing CMC data package, URS, Qualifications, Process development report, BMR & implementation of Quality system. Engaging himself / herself in frequent scientific discussions, constant learner & responsible for targeted deliverables. Preferred candidate profile Candidate should be well versed with latest developments in Upstream related Instruments, Cell culture & Bioreactor process for implementing techniques towards developing the robust process in time bound manner. The candidate should be a very good team player and comfortably connect inter & intra departmental teammates with an expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. A clear and convincing oral and written communication in English is desired. He / She should have the good working knowledge of MS office, handling statistical software and related analytical tools. Senior Scientist/ Principal Scientist, preferably PhD /post docs from abroad having Bioprocess cell culture experience.

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