Sr Process Chemist -Manufacturing, Science & Technology (MS&T)
Location: Indianapolis, Indiana
Internal Number: 322131BR
769 million. That's how many lives are touched by Novartis products globally.
The Sr. Process Chemist owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s).
Your responsibilities include, but are not limited to: * Maintain the oversight and knowledge for entire manufacturing process performed on site throughout the entire commercial lifecycle, act as SPOC. * Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.). Create Process Validation protocols and generate reports. * Monitor critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending. * Lead/support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams. * Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed. * Operation of the MS&T Laboratory. * Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place, support improving the control strategy where applicable. * Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.