Generic API expertise:  Process chemistry, CPP and CQA studies, DoE,  fate and purge studies, impurity mining, PAR and NOR studies,                 polymorphism, control of genotoxic components, tracking of residual heavy metals. Familiar with documentations related to cGMP synthesis. Preparation of Development report for API, TTD by aligning with DQA requirements. BMR reviews.

Leading a team of research scientists (8 members) and providing needful motivation to increase output.Handling of small scale to kilo scale projects by process research development.Process safety studies evaluations based on critical process parameters.ExperienceImplementing of alternative schemes as per requirement.Evaluating impurity profiling of raw materials, drug intermediates and preparing its related impurities and developing the control measures.Trouble shooting of scale up bathces, cost evaluation of process and process optimization.Good coordination with production, QA, QC and ADL along with CFTs (Purchase, BD, PM and stores).Knowledge in preparation of Technology packages, weekly updates, Development & campaign reports. Expertise reviewing the protocols like campaign reports, BMR, and the results of the carried work.Experienced to work under GMP conditions and producing intermediates as per ICH guidelines as well as customer requirements.Good knowledge in preparing the costing sheets and RFP. Leading process & product related deviation investigation, propose CAPA & change controls.

Leading a team of research scientists (4 members) and providing needful motivation to increase output.Handling of small scale to kilo scale projects by process research development.Rocess safety studies evaluations based on critical process parameters.ExperienceImplementing of alternative schemes as per requirement.Evaluating impurity profiling of raw materials, drug intermediates and preparing its related impurities and developing the control measures.Trouble shooting of scale up bathces, cost evaluation of process and process optimization.Good coordination with production, QA, QC and ADL along with CFTs (Purchase, BD, PM and stores).Knowledge in preparation of Technology packages, weekly updates, Development & campaign reports. Expertise reviewing the protocols like campaign reports, BMR, and the results of the carried work.Experienced to work under GMP conditions and producing intermediates as per ICH guidelines as well as customer requirements.Good knowledge in preparing the costing sheets and RFP. Leading process & product related deviation investigation, propose CAPA & change controls.

PROCESS R&D Plant support process R&D for scale up batches and downstream process development for purification of process scale up to pilot plant to commercial plant.

Process R&D

Process R&D