Job Functions:

• Lead and facilitate continuous improvement initiatives across all INCOG functions including Manufacturing, Quality, Supply Chain, Technical Services, Engineering, and Business Operations.

• Develop and implement a comprehensive continuous improvement strategy aligned with INCOG’s business objectives and operational goals.

• Facilitate kaizen events, value stream mapping exercises, and process improvement workshops to identify and eliminate waste, reduce cycle times, and improve operational efficiency.

• Apply Lean Manufacturing and Six Sigma methodologies (DMAIC, 5S, visual management, standard work, etc.) to drive measurable improvements in key performance indicators.

• Partner with department leaders to identify improvement opportunities, prioritize projects based on business impact, and develop implementation roadmaps.

• Establish and maintain continuous improvement metrics, dashboards, and reporting systems to track progress and communicate results to leadership.

• Coach and mentor employees at all levels in continuous improvement tools, methodologies, and problem-solving techniques to build organizational capability.

• Lead root cause analysis activities for complex operational challenges, utilizing tools such as fishbone diagrams, 5 Whys, and statistical analysis.

• Develop and maintain standard work documentation, process flow diagrams, and visual management systems to sustain improvements.

• Collaborate with Quality and Operations teams to ensure continuous improvement initiatives maintain compliance with FDA, EMA, and other regulatory requirements for GMP manufacturing.

• Facilitate cross-functional problem-solving teams to address operational challenges and implement sustainable solutions.

• Benchmark industry best practices and introduce innovative approaches to operational excellence within the CDMO environment.

• Support change management activities to ensure successful adoption and sustainability of improvement initiatives.

• Participate in key meetings and audits as needed to represent INCOG’s continuous improvement capabilities and culture.

Candidate Requirements:

• Bachelor’s degree in Engineering, Operations Management, Business, or related scientific field.

• Lean Six Sigma certification (Green Belt minimum; Black Belt preferred).

• Minimum of 7-10 years of experience in operations, process improvement, or continuous improvement roles, with at least 3-5 years in pharmaceutical, biotechnology, or other highly regulated manufacturing environments.

• Demonstrated experience leading successful continuous improvement projects with measurable results (cost reduction, cycle time improvement, quality enhancement, etc.).

• Strong knowledge of Lean Manufacturing principles, Six Sigma methodologies, and continuous improvement tools and techniques.

• Proven ability to facilitate cross-functional teams and drive consensus in a collaborative environment.

• Strong project management skills with ability to manage multiple initiatives simultaneously.

• Exceptional communication and presentation skills, with ability to influence at all organizational levels.

• Experience with change management principles and practices.

• Proficiency with process mapping software, visual management tools, and data visualization platforms.

Additional Preferences:

• Experience with high growth companies and scaling operations.

• Lean Six Sigma Black Belt or Master Black Belt certification.

• Experience in aseptic manufacturing, fill-finish operations, or parenteral drug product manufacturing.

• Familiarity with packaging and labeling operations, inclusive of serialization.

• Experience with combination products or device assembly operations.

• Knowledge of manufacturing execution systems (MES), quality management systems (QMS), and ERP systems.

• Previous experience coaching and developing continuous improvement practitioners.