• Handling formulation development team for Complex Injectables including Liposomes, nanosuspensions, peptide drug delivery, iron complexes and Lyophilized Injectables US, Canada and Europe market• Providing strategic and operational leadership in the generation of all CMC technical and regulatory documents (US market) and responsible for interacting with Quality and Regulatory departments for the integration of these documents for regulatory submissions• Finalizing the requirements for designing manufacturing SKIDs along with CFTs requiredfor executions of complex injectable dosage forms at the plant• Provide strategic guidance to the launch team, through a review of data and information andmonitoring the technical progress of the projects in line with the project goals.• Ensuring that all project activities are supported by proper documentation per regulatorysubmission requirements.• Liaise with the plant operation team to ensure that experimental trials/registration batchesare planned and executed in a timely manner.• Pro-active management of several projects ranging in complexity from API sourcing todevelopment to launch including transfer of the process to manufacturing sites / CMO sites.• Review and evaluate data on lab trials and make recommendations for bio/stability studybatches and communicate these recommendations with management/peers to get thenecessary clearance to proceed further.• Apply QbD/ DoE principles to product development by conducting suitable trials to study the impact of variations on the manufacturing process parameters in order to recommend control strategy for CMAs and CPPs.• Responsible for responding to deficiency queries from regulatory agencies.• Possess a detailed understanding of the theoretical principles for major manufacturing anda working knowledge of the equipment used in the manufacturing processes and ensuresuccessful execution of experimental trials/registration batches on the floor.

Working on NDDS products like liposomal injections and nanoemulsions. Handling peptide based injectable products.

• Handling formulation development team for Complex Injectable/ Lyophilized Injectables as well as Oral dosage forms for US, Europe, Australia and RoW market• Responsible for designing and planning of lab scale product development as per the QbDconcepts (with application of DoE) for various products as per the ICH guidelines• Successfully filed Complex injectables, Lyophilized injectable/ Injectable products and oral dosage forms for US/EU and Canada market• Responsible for planning exhibit batches of products by coordinating with cross-functionalteams.• Responsible for planning and execution of formula and process optimization of products atboth lab scale and plant level• Responsible for dealing with CFTs for deciding the timelines of projects• Finalization of instruments/equipment required for new projects at plant by discussingwith vendors for finalizing the URS• Responsible for designing the SKIDs /machineries as per product requirements bycoordinating with the Production and planning department.• Responsible for approval of documents required for regulatory submissions for various dosage forms• Responsible for preparing responses for CRL/deficiencies received from regulated (US/EU/Australia) and RoW countries for filed projects.• Attending telecons with clients and providing them timelines /feedback on the projects onweekly basis

Working as a Regional Manager.Promotion of new excipeints for pharmaceutical dosage forms.Giving presentations on excipients in R&Ds and helping scientists in formulation development.Helping scientists in understanding the criticalities of the excipients and use of these for formulation development.

•Worked on NDDS products like liposomes, microspheres, nanocrystal technology •Worked on Suspension, Injectable & Complex Generics (Liposomal) Product Development•Product Development & Scale Up Feasibility Assessment, Execution of Pre-formulation & Formulation Trials•Optimization Prototype Formula & evaluation or Interpretation of stability results, Preparation of Official Documents, Co-ordination With Cross Functional Teams•Preparation Strategy Design Note for Critical Injectable Products •Development of products with identification of QbD elements such as QTPP, CQA, CMA, FMEA, etc. •Involved in feasibility assessment of complex parenteral generic (Liposome and micellar) products development.•Scale up and commercialization of the developed technologies, •Applying IVIVC, QBD and DoE during formulation development and its successful implementation.