Leading TAT function and Delivery - CPS functions in CTO-6 and SEZ

 Providing scientific support for process development of an API by identifying the Critical Process parameters (CPP), Critical Quality attributes (CQA), Source of Variability for each unit operation and mitigate the risk of scale up and optimize the process in order to achieve the “Targeted Product Profile (TPP).  Validation-Developing new products by Designing, Planning and Executing process optimization studies to ensure process robustness and to improve quality, safety, cost and productivity. Identifying and mitigating the risks in the project by anticipating the problems for Process Scale up and Validation. Optimizing process parameters by planning of result oriented experiments, what if’s and concluding by interpretation of analytical data. Pilot plant trial for optimization, fine tuning of cost reduction process and to understand/monitor critical process parameters at pilot scale to avoid failure in commercial scale. Process equipment selection, design and facility creation with respective Process requirement, Safety & Cost Effectiveness. Commercial out-sourcing of intermediates to external contract manufacturers. Execution of the Trial and Validation batches at scale to achieve consistent yield and quality and to instill confidence to manufacturing to process further commercial campaign. Intense co-ordination with various functions like R&D, Manufacturing, Quality Control, Quality Assurance, Intellectual Property Management, Regulatory Affairs for timely completion of process validation to file Drug Master File. Driving project to complete it Timely without adhering the schedule to achieve customer delight. Self motivated efforts towards unplanned- developments, risk mitigation and cost reduction to the advantage of the company.

scale up and process engg

Leading group of associates for validation services. Preparation of validation master plan for pharma and Biotech projects. Validation of process equipments, facility, clean utilities, process control software and building management system, heating ventilation and air conditioning system for biotech and pharma.  Development of validation protocols such as DQ, IQ, OQ & PQ for all equipments, process validation, cleaning validation and Facility Qualification protocols.  Completed project-BIOCON (Syngene International Limited) entire facility validation for custom research and development.  Worked with Emersion and Trane for setting up Process control and Building management system for Biological pilot plant (Syngene International Limited). Qualified more than 200 equipments for various biopharmaceutical companies around the globe.

Leading group of Chemical engineers for scale up of new products, NPD. Project risk mitigation with proper planning of raw material & Equipment. Driving project to complete it Timely without adhering the schedule to achieve customer delight. Costing of project, Facility creation comply with cGMP & GEP guidelines, Process equipment and process control selection with respect to process requirement, operational convenience, Safety & cost effectiveness. Trouble-shooting of the process during the trial phase of scale up. Execution of validation and Trail batches at pilot plant scale and commercial scale. Equipment selection, Equipment sizing and facility creation, Generating scale-up parameters and data during pilot plant. Selection of suitable equipment for scale-up in commercialization of new drug from R&D, Technology Transfer from R&D to Pilot Plant and then to plant. Planning and scheduling of trial and validation campaign for new products. Training the shop floor people wrt to process, safety & operations in detail.

 Responsible for running operations smoothly to meet pre-set production targets. Production planning on weekly/monthly/yearly basis as per annual production plan with available capacity. Identify and initiate measures to improve production methods, equipment performance on productivity and quality aspect. Upkeep the GMP and prepare for quality and safety audits. Assist the Head of Department for studying areas of improvement, implementation of improvement actions for optimization of process and housekeeping, environment and safety Assisting shift operators in technical issues and troubleshooting. Validated Single fluid heat transfer system & auto solvent dispensing system, Agitated thin film evaporators, rising film evaporator, reactors, dryers, filters, distillation column, extraction column, Fermenters which include both Auto and manual system. Participated in Internal audits and Customers audits and acted as Team player in cGMP compliance during WHO, Certificate of suitability(British) , USFDA and ISO 14000 & 9000 series standards Real time experience in oracle as end user. Participated in Cleanroom, process validation, cleaning validation, equipment qualification, annual product review of both sysnthetic and biological products.

 Responsible for running operations smoothly to meet pre-set production targets. Production planning on weekly/monthly/yearly basis as per annual production plan with available capacity. Identify and initiate measures to improve production methods, equipment performance on productivity and quality aspect. Upkeep the GMP and prepare for quality and safety audits. Assist the Head of Department for studying areas of improvement, implementation of improvement actions for optimization of process and housekeeping, environment and safety Assisting shift operators in technical issues and troubleshooting. Validated Single fluid heat transfer system & auto solvent dispensing system, Agitated thin film evaporators, rising film evaporator, reactors, dryers, filters, distillation column, extraction column, Fermenters which include both Auto and manual system. Participated in Internal audits and Customers audits and acted as Team player in cGMP compliance during WHO, Certificate of suitability(British) , USFDA and ISO 14000 & 9000 series standards Real time experience in oracle as end user. Participated in Cleanroom, process validation, cleaning validation, equipment qualification, annual product review of both sysnthetic and biological products.