Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, and a wholly owned subsidiary of Dr Reddy's Laboratories Ltd. Aurigene is focused on precision - oncology and has multiple compounds at different stages of pre-clinical development and several products in pipeline in clinical development.
Post : Manufacturing Lead - Cell Therapy
Job Description :
• Candidate have to lead different Cell Therapy Manufacturing programs. Involve in full-cycle plan for the products including successful technology transfer from collaborators, process development, GMP validation and production to take the therapy into trials and commercialization.
• Extensive experience in mammalian cell culture techniques and large-scale bioreactors of biologicals for commercial and clinical requirement.
• Experience in Cell Therapy space and viral and non-viral methods of gene transfer will be preferred.
• Ability to determine, develop and present technical process improvement recommendations to appropriate groups, keeping abreast with the latest technologies in cell therapy product development.
• To understand systems and processes pertaining to sterile practices, work ethics, safety, health in a GMP environment. Thorough understanding of regulatory and GMP guidelines and critical quality attributes in Cell Therapy space will be preferred..
• To participate actively during compliance monitoring inspections and regulatory agency interactions. Prior experience in facing regulatory audits will be preferred
Candidate Profile
M.Sc/M.Tech in Life Sciences with 14-15 years of experience or PhD/Post Doc in Life Sciences with 8-10 years of experience in GMP Production involving intense Mammalian Cell Culture as in areas of Cell Therapy, Vaccine, Biosimilar or Stem Cell Manufacturing.
Job Location : Bangalore
Interested candidates may share their resumes to : joby_f@aurigene.com
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