Above 20 years experience in Sterile manufacturing includes (WH, Production , Packing , dispatch, Maintenance, Operational excellence & Technology transfer ), Projects - commissioning, Operationalization, Team development , meeting Regulatory audits technology transfer, Production Planning & control . Currently working as cluster head for two JVs operations of Aurobindo pharma . Overall Plant operations consisting of Injectable(Dry powder, Lyo and Liquids), OSDs (Tablets , Capsules& Soft Gelatin) & Sterile API manufacturing, warehouse, plant SCM , Engineering, Future expansions projects, Budgeting, Operational excellence and MSAT . Resourceful at strategizing maximum utilization manufacturing capacity, manpower and machinery to meet business need. Leading collaboration projects, Project management from development to ANDA filing. Hands on experience in formulation, filling – packing of combination vaccines like DTwP, HB, Quadruple, penta-valent , hexa-valent and biopharmaceuticals like Insulin & its analogues, Biosimilar mabs etc…. Working experience in different presentations of sterile formulations like Vials . Ampoules, Dry powder filling, Large volume parentrals, lyophilisation, Pre-filled syringes, cartridges and Form fill seal technologies. Manufacturing Consists of Clinical study batch size to big commercial size manufacturing. Working experience with Multi-racial team. Team development for production and quality optimizations, Document / validation developments, Training plan to develop SMEs, Compliance awareness and facing regulatory. Involved in regulatory audits USFDA, EU GMP, INVISA, WHO Geneva. M.Pharm (Medicinal chemistry) from Department of Pharmaceutical Sciences, Nagpur University.
Listed skills include Management, V&V, Pharmaceutical Industry, Regulatory Affairs, and 12 others.
