Working on Bupivacaine liposomal injections Long-acting depot injections for schizophrenia (PLGA Based) 505 b2 modified release formulations for CNS and CVS indications. Developing dry powder inhaler for COPD.

Developing mAb SC and IV injections for CNS disorders. 2023-06-06.2024 drug product -small and large molecules Key leader and advisor managing complex solid oral and injectable drug product development of small and large molecules for global markets. Handling products within a wide range of therapeutic areas like Respiratory, CNS, CVS, Diabetes, Gastroenterology, Oncology, Dermatology, Infectious Diseases and Renal or Metabolic disorder. Responsible for making global regulatory strategies and supporting the R&D and commercialization of innovative products across the portfolio. Leading transformation initiatives to build a fit-for-purpose organization that can drive business priorities. Developed risperidone long-acting depot injections (Risperdal Consta) based on PLGA microspheres technology. Management of external research programs with academia and partners located globally. Responsible for developing an R&D strategy (formulation and analytical) to enable business priorities for sustainable growth. Oversee scientific operations that include portfolio selection, portfolio maximization opportunities, product development strategy, new product filings, deficiency response, approvals, capability building, and external partnerships. Collaborate and partner with University, CRO, CDMO and drug product developer for managing cross-functional issues. Managing budget, resources, timelines, communication with agencies. Management of development, Stability, identification of suitable CDMO, Dossier Filling and launch and commercialization.

Supervising a team of formulation and analytical scientists and responsible for strategic planning and project management, budget from initiation to commercialization of innovative and value added oral targeted as well as sustained release formulations for CNS molecules, multiple sclerosis, epilepsy etc. Managing budget, resources, timelines, communication with agencies. Management of galenical and analytical development, clinical phases, validation & tech transfer, QC & Stability, identification of suitable CDMO, Dossier Filling and launch and commercialization of solid oral, liquids drug products, and long-acting prefilled drug product devices. Successfully developed following formulations: 1) Long-acting drug device i.e prefilled syringe for schizophrenia drugs. 2) Sustained release oral formulation for BCS class II anticonvulsant drug. 2) Oral modified (24-hour release) alcohol resistant coated mini-tablet formulation. 3) Liquid syrup and injectables for anticonvulsant and various CNS drugs.

Worked on Biosimilar development and launched four biosimilar products for the therapy of autoimmune, oncology, and oncohematology illnesses. Formulations of small and large molecules using advanced drug delivery. Developed innovative formulation for factor Xa inhibitor (poorly soluble oralanticoagulant) with enhanced bioavailability for 505 (b) (2) application. Evaluated new CMOs for technical capabilities and developed and transferred the technology of products to the CDMO sites globally. Managed multiple complex projects and met all pertinent milestones.

Established a team and a new laboratory (layout with scientific inputs, equipmentsprocurement etc) for solid oral platform technology group for NCE and biological molecule drug product development. Developed colon targeted drug delivery using Hot Melt Extrusion Technology. Set Up a continuous manufacturing process using a twin-screw extruder for development of stomach targeted drug delivery. Established proof of concept (PoC) for bioavailability enhancement and sustained release formulation using Hot Melt Extrusion technology. Worked on Cyclodextrin complexation and nanoparticulate system for enhancement of solubility for BCS class II drug. Long-acting depot nanosuspension using HPH/bead mill of Paliperidone. Developed Leuprolide acetate long-acting depot injections (Lupron Depot®) based on PLGA microspheres technology.