Continuous Improvement Manager

INCOG Biopharma Services in Indianapolis, IN is hiring a Continuous Improvement Manager with a passion for driving operational excellence and fostering a culture of continuous improvement across all functions of INCOG’s organization. The CI Manager will be skilled in Lean Manufacturing, Six Sigma methodologies, and change management principles, with the ability to lead cross-functional teams through transformational projects.

The Continuous Improvement Manager will work closely with Leadership Team members. This role will lead the strategy and implementation of continuous improvement initiatives that enhance operational efficiency, reduce waste, and improve quality outcomes in support of accelerating delivery timelines while maintaining compliance with GMP regulations and global health authority expectations.

The CI Manager will be instrumental in building and sustaining INCOG’s culture of continuous improvement by embedding Lean principles, facilitating kaizen events, developing standard work, and coaching team members at all levels. Excellent analytical, problem-solving, and communication skills are critical, with the ability to clearly articulate complex process improvements and data-driven insights to diverse audiences. The Continuous Improvement Manager will exemplify strong interpersonal skills and be capable of influencing positive change without direct reporting authority, building collaborative relationships across all levels of the organization.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

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.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.