Executive – MSAT

• To be involved in the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing).
• To work with R & D / Pilot plant and other cross functional teams for execution of experimental runs and any other scale down experiments to support manufacturing process changes for both microbial and mammalian processes.
• To be involved in the implementation of process changes for mammalian and microbial processes brought by process development.
• Ensure successful production runs by assessing risk, setting preventive measures in place, process improvement, investigating, troubleshooting process issues for microbial as well as the mammalian processes.
• Involve in the troubleshooting and assessment of process related deviations (OOS, OOT) / investigation to identify the root cause and provide an appropriate CAPA.
• Monitoring of ongoing manufacturing processes (microbial and mammalian), data acquisition, data trending and process improvement activities.
• To be involved in preparation/review and timely closure of technical documents i.e., manufacturing batch records, master formula records and SOPs as per requirement.
• Involved in preparation/review and ensure timely closure of protocols and reports related to process validation, process characterization, scale up –scale down, hold time studies and resin usability on need basis

• 2-3 years of experience in R&D  / Manufacturing in Pharma Biotech
• Preparation of technical documents, development reports, batch records, validation protocols
• Experience handling process trouble shooting and deviations

Post Graduation in Biotechnology