Amneal Pharmaceuticals, Ahmedabad, Gujarat is looking for experienced Regulatory Affairs professionals with strong expertise in Biologics/Biosimilars for global markets including USFDA and EMA. They are seeking professionals with strong regulatory expertise, strategic thinking, and the ability to work in a cross-functional environment. This role involves end-to-end regulatory ownership across development, submissions, and lifecycle management for large molecule products. What they are specifically looking for : - Hands-on experience in regulatory submissions (IND/BLA/ANDA, IMPD/MAA) -Strong understanding of CMC for biologics (cell line, upstream/downstream, analytical, validation, comparability) -Experience with biosimilar regulatory pathways (USFDA 351(k), EMA) -Ability to handle regulatory queries, deficiency responses, and global lifecycle activities -Exposure to sterile/injectable or specialty biologics is an added advantage Qualification Required: M.Ph...
Required Manufacturing Associates(Freshers and early-career professionals are encouraged to apply.)- B.Tech / M.Sc / M.Tech in Biotechnology or related Life Sciences discipline
Join the Team Building India's Largest Viral Vector Manufacturing Facility (500L+) Cellogen Therapeutics is hiring Manufacturing Associates to join their Cell & Gene Therapy - Lentiviral Vector Manufacturing Team. Be part of a pioneering mission to scale advanced viral vector manufacturing in India. Details of the available position is provided below 1. Open Position: Manufacturing Associates (Freshers and early-career professionals are encouraged to apply.) 2. Eligibility Criteria: B.Tech / M.Sc / M.Tech in Biotechnology or related Life Sciences discipline -Knowledge of mammalian cell culture -Understanding of molecular biology techniques (PCR, qPCR, etc.) -Familiarity with protein purification processes -Prior experience in GMP/GLP facilities is an added advantage 3. Key Responsibilities: -Execute upstream and downstream processing -Support scale-up operations from 50L to 500L+ lentiviral vector manufacturing -Maintain compliance with GMP protocols and qual...