Lead and support implementation of continuous improvement initiatives by monitoring production performance and identifying opportunities for operational excellence. Develop, coach, and advance Lean and continuous improvement skills across the manufacturing organization. Participate in pre and post campaign planning for Drug Products and APIs, ensuring lessons learned are incorporated for future success. Assist or lead Root Cause Analysis and Corrective/Preventative Actions (CAPA) for operational deviations. Ensure timely follow-up and closure of operations-related CAPAs and compliance actions. Uphold all Quality, Safety, and Environmental SOPs, acting as a role model and championing positive compliance interventions. Update and implement changes to Operating SOPs as needed. Represent operations teams in New Product Introduction (NPI) projects. Collaborate on manufacturing and site strategy development and execution.
Degree (ideally Masters or PhD) in Life Sciences, Chemical Engineering, or Process Engineering. Strong working knowledge of API/Drug Product processing, unit operations, and operational excellence/continuous improvement methodologies. Lean Six Sigma qualification or relevant knowledge is highly desirable.
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