Group leader to lead mAB development and production division
Adv No: BT/CC/GL/26-2-2022
We are looking for Group leader to join the mAB development and production division to lead the efforts for developing and optimizing cell culture process including media development, feeding strategies, process parameters optimization, process characterization and scale-up for large scale production of monoclonal antibody development from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop phase-appropriate upstream processes (bioreactor, transfection, infection, microfiltration, filtration) for clinical supply production, and further optimize/scale up these processes to enable transfer of robust processes to the commercial space.
Overall Competency
Provide leadership and technical direction for development and execution of overall processes development for mammalian therapeutic proteins and mAb candidates
Expertise and technical knowledge in mammalian therapeutic proteins and mAb development encompassing R&D, Manufacturing, Quality and Regulatory functions.
Develop and optimize the cell culture parameters and nutrient requirements in shaker flasks and bioreactors (10L) for mammalian suspension cell growth for therapeutic proteins and antibody production.
Develop and optimize the transient transfection or stable cell line production process to maximize the yield.
Ability to analyze complex data and reach valid scientific conclusions
Deliver product specific documentation and reports ensuring appropriate quality of documentation to support inclusion of data and information in regulatory filings.
Author and review technical document and reports to support RCGM, CDSCO filings.
Work with a high degree of independence to lead R&D projects and contribute to project planning.
Update and familiar with current and relevant scientific literature.
Technology transfer of methods from R&D to manufacturing
Provide updates and presentation of results at internal and external meetings
Represent the group at regulatory inspections and during audits
Ensuring a clean, organized and sterile cell culture lab environment
Train and mentor junior scientists or executives, providing scientific and technical expertise and guidance
Interact with other departments and teams involved within the company
Qualifications:
PhD in Cell biology, Biotechnology, Bioengineering or a related field. PhD with minimal 5+ years' relevant experience, or M.Sc. with 10+ years relevant experiences.
Mammalian cell culture experience of 5 years with various adherent cells and suspension cells such as HEK293 and CHO cells is required.
Interested candidates may apply to this position by sending their CV to careers@bycusbio.com
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Last Date 15th March 2022
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