Operational Excellence Leader

This is a fully remote position, open to applicants in California, +5 more states.

📋 Description

• Take charge of the production system development throughout the entire Make value stream, from the reception of materials to readiness for release.

• Perform quick diagnostics and convert insights into organized deployment roadmaps.

• Establish and maintain tiered daily management, standard work for leaders, visual performance management, SQDC boards, KPI ownership, and structured escalation processes.

• Manage the kaizen funnel, directing events and workshops aimed at enhancing yield, cycle time, efficiency, first-time execution accuracy, changeovers, and manufacturing-to-quality transitions.

• Convert site and business goals into actionable floor-level priorities via strategy deployment / Hoshin Kanri.

• Link operational performance to throughput, sellable capacity, client commitments, release cycle time, first-time execution accuracy, inventory, working capital, and costs.

• Develop and uphold a transformation scorecard to monitor KPI performance, value capture, and tracking of countermeasures.

• Utilize MES, electronic batch records, shop-floor data systems, analytics, digital tools, and AI tools to support daily management and identify abnormalities.

• Guide and mentor A3 and PSP structured problem-solving at the Gemba.

• Lead value stream mapping throughout the batch lifecycle, including transactional and quality flows, batch-record reviews, deviation management, and client responses.

• Collaborate with Quality on the operating-system components of the release maturity roadmap.

• Implement the production system for tech transfer and new product introductions.

• Coach and nurture supervisors, operators, and emerging practitioners in standard work, daily management, structured problem-solving, and Lean principles.

• Own and standardize the production-system framework, incorporating established working methods, governance routines, and accountability mechanisms.

• Organize benchmarking and analysis of external best practices.

• Travel across the North American ATD footprint and collaborate with Quality and Manufacturing leadership at each site.

• Transition ownership of the production system to site teams.

⛳️ Requirements

• Bachelor’s or master’s degree in life sciences, chemical engineering, biochemical engineering, or a related field, or a comparable combination of education and experience.

• Over 10 years of experience in a GMP-regulated manufacturing setting.

• More than 8 years of hands-on Lean accountability for process performance throughout the Make value stream.

• Extensive experience in chemical or pharmaceutical synthesis and GMP manufacturing.

• Practical experience in deploying and maintaining a production or business operating system in a line role, covering strategy deployment, tiered daily management, kaizen, standard work, visual management, and structured problem-solving.

• Proven history of achieving measurable, sustainable business results through transformation in areas such as safety, quality, delivery, throughput, yield, cycle time, cost, or client performance.

• Strong command of structured problem-solving and root-cause analysis methodologies.

• Capacity to coach operators and influence senior management.

• Willingness to travel significantly to NASD facilities in Frederick and Boulder, Colorado, and throughout the broader ATD footprint.

• Experience in Lean manufacturing within a complex or regulated manufacturing environment is advantageous.

• Familiarity with tech transfer, process validation, or new product introductions in biologics or pharmaceutical manufacturing is a plus.

• Lean, Six Sigma, TPS, or Danaher Business System certification is a plus.

🏝️ Benefits

• Eligibility for bonus opportunities.

• Stock options.

• Comprehensive benefits package.

• Flexibility to work remotely.

• Commitment to equal employment opportunities and support for an inclusive workplace.

• Disability assistance available during the application or interview process.