• Experienced as a member of site leadership team, driving tech. strategies, continuous improvements & frontline support
• Experienced as Process Technology lead for greenfield vaccines manufacturing facility CAPEX project
• Expertise in design, scale-up & optimization of bio-processes through engineering/scientific principles
• Well-versed with upstream/downstream processing, cleaning & sterilization in biologics manufacturing
• Background in providing technical support to commercial microbial & cell culture based GMP processes
• Well versed with overall GMP compliance related to process robustness, deviations, RCAs and state of validation
• Knowledge of commissioning & qualifying GMP equipment along with process/cleaning validation
• Expertise in capacity optimization through process-schedule modeling and debottlenecking
• Seasoned professional in cause-effect investigation using SPC & multivariate data analysis methods
• Championed CFD methodology to solve problems associated with fermenters, mixing systems & HVAC
• Drove process scale-up and improvements through assessment & technology transfer of single-use tech.
• Exposure to project management through reviewing framework, timelines, deliverables and resources