Principal Scientist- Upstream Process Development

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 analysing 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.

• Principal Scientist, preferably PhD /post docs from abroad having Bioprocess cell culture experience.