Nikhil Kawachale

Director - Global Process Engineering (Biologics, Cell & Gene), Takeda

• 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