Continuous Improvement Manager Summary
We are seeking a Continuous Improvement Manager with a passion for driving operational excellence and fostering a culture of continuous improvement across all functions of our organization. The 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 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 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.
Essential 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.
Special Job 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.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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