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We are seeking a Continuous Improvement Associate with a passion for hands-on process optimization and a drive to support operational excellence across our organization. The Associate will apply Lean Manufacturing, Six Sigma methodologies, and data analysis skills to execute improvement projects, solve operational problems, and sustain gains achieved through continuous improvement initiatives.

Reporting to the Continuous Improvement Senior Manager, the Continuous Improvement Associate will serve as a key contributor in executing the organization's continuous improvement strategy. This role will work directly on the shop floor and within cross-functional teams to collect and analyze data, identify process inefficiencies, implement solutions, and sustain improvements that enhance operational efficiency, reduce waste, and improve quality outcomes-all while maintaining compliance with GMP regulations and global health authority expectations.

The Associate will actively contribute to building INCOG's culture of continuous improvement by applying Lean tools, leading kaizen events, developing and maintaining standard work, and supporting the coaching and development of team members. Strong analytical, problem-solving, and communication skills are essential, along with the ability to work collaboratively across departments and present data-driven findings to diverse audiences. The Associate will demonstrate strong interpersonal skills, a willingness to learn, and the initiative to drive positive change at the operational level.

Essential Job Functions:

Execute continuous improvement projects across INCOG functions including Manufacturing, Quality Assurance, Quality Control, Supply Chain/Warehouse, Technical Services, Engineering, and related business areas under the direction of the Continuous Improvement Senior Manager.

Support the development and implementation of the continuous improvement strategy by conducting data collection, process analysis, and baseline assessments to identify improvement opportunities.

Lead and 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 tools (DMAIC, 5S, visual management, standard work, etc.) to drive measurable improvements in key performance indicators.

Collect, analyze, and interpret process data using statistical methods to identify trends, root causes, and opportunities for improvement; present findings and recommendations to stakeholders.

Develop and maintain continuous improvement metrics, dashboards, and visual management boards to track project progress and communicate results.

Support the coaching and training of employees in continuous improvement tools, methodologies, and problem-solving techniques to build organizational capability.

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

Create, update, and maintain standard work documentation, process flow diagrams, and work instructions 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.

Support cross-functional problem-solving teams by gathering data, preparing analysis, and helping implement sustainable solutions.

Research and benchmark industry best practices and contribute innovative ideas for operational excellence within the CDMO environment.

Support organizational change management activities, including stakeholder analysis, change impact assessments, communication planning, and adoption tracking, to ensure successful implementation and sustainment of improvement initiatives across the organization.

Participate in Gemba walks, time studies, and process observations to identify waste and improvement opportunities at the operational level.

Support the design, implementation, and sustainment of visual management systems across operational areas, including performance boards, status indicators, and workplace organization standards to promote transparency and real-time decision-making.

Support the development and execution of tiered daily management systems (e.g., Tier 1/Tier 2/Tier 3 huddles), including preparation of huddle board content, facilitation of frontline team meetings, escalation tracking, and alignment of daily operational performance to site-level objectives.

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 3-5 years of experience in operations, process improvement, or continuous improvement roles, with at least 1-2 years in pharmaceutical, biotechnology, or other highly regulated manufacturing environments.

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

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

Ability to collect, analyze, and interpret data using statistical tools and software.

Strong problem-solving skills with experience applying structured root cause analysis methodologies.

Effective communication and presentation skills, with the ability to convey data-driven insights to technical and non-technical audiences.

Ability to work collaboratively across functions and contribute positively to team-based environments.

Proficiency with process mapping software, data analysis tools (e.g., Minitab, Excel), and data visualization platforms.

Additional Preferences:

Experience with high growth companies and scaling operations.

Lean Six Sigma 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.

Experience with project management tools and methodologies.

Familiarity with change management principles and practices.

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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