Sr. Specialist, Operational Excellence - #262770

Formerly Summit Biosciences Inc. | KDD


Date: 16 hours ago
City: Lexington, KY
Contract type: Full time
Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

As a Senior Specialist, Operational Excellence, you will play a key role in driving performance and fostering a culture of continuous improvement across our Lexington manufacturing site. You will lead cross-functional initiatives that improve efficiency, reduce waste, and enhance quality using Lean, Six Sigma, and structured problem-solving methodologies. Your ability to influence, coach, and collaborate will be critical in embedding operational excellence into our daily operations and ensuring long-term business success.

Responsibilities:

Process Optimization and Continuous Improvement

  • Lead value stream mapping, Kaizen events, and other lean activities to eliminate waste and improve efficiency
  • Use Lean and Six Sigma tools to assess operations and implement sustainable improvements
  • Collaborate with cross-functional teams in Manufacturing, Quality, Supply Chain, and Engineering to align on project goals and outcomes
  • Develop and implement standard work and best practices for operational consistency
  • Promote a continuous improvement culture through coaching and mentoring

Training and Change Enablement

  • Coach and train employees at all levels on OE tools and concepts
  • Support deployment of site-level OE strategies and cultural transformation initiatives
  • Facilitate structured problem-solving and root cause investigations (e.g., A3s, 5 Whys, Fishbone)

Performance Monitoring and Analytics

  • Track key performance indicators (KPIs) to evaluate process effectiveness
  • Develop visual management systems and dashboards to support performance tracking
  • Utilize data to identify trends, drive decision-making, and report project ROI

Compliance and Governance

  • Ensure OE initiatives comply with cGMP and regulatory requirements
  • Support CAPA and Change Control development related to performance improvement
  • Contribute to OE documentation, SOPs, and standardization efforts across the site

Qualifications:

Basic Qualifications:

  • Bachelor’s degree in Engineering, Operations, Business, or a related field
  • 5+ years of experience in a manufacturing or operations environment
  • Lean Six Sigma Green Belt certification
  • Demonstrated success leading continuous improvement projects
  • Strong communication and facilitation skills
  • Comfortable working cross-functionally and influencing without authority

Preferred Qualifications

  • Experience in pharmaceutical or GMP-regulated manufacturing
  • Black Belt certification
  • Familiarity with digital tools (Power BI, operational dashboards)
  • Experience training or coaching teams in Lean/Six Sigma tools

Physical Requirements:

  • Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position
  • Employees are required to follow all cGMP and safety procedures
  • The employee must wear all required safety equipment and perform assigned work in a safe manner
  • Must use proper lifting techniques and be aware of hazards
  • The employee must occasionally lift and/or move up to 20 pounds

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