SMS Area Lead - Drug Product

Role Summary

SMS Area Lead - Drug Substance. The role serves as the Operational Excellence (OPEX) representative in a specific department, driving continuous improvement, supporting performance initiatives, advancing SMS maturity, and leading problem-solving efforts using SMS tools.

Responsibilities

• Being the OPEX representative for a specific department(s) and/or Process Centric Units (PCUs)
• Support the deployment and maturation of SMS 2.0 operating standards as defined in respective ecosystems
• Ensure milestone adherence for SMS area‚Äôs roadmap
• Support the assigned area with performance measurement, analysis, reporting, and corrective/preventive action
• Supporting execution of performance initiatives including the Continuous Improvement project portfolio defined for this area, and deployment of operating standards as codified in the respective ecosystems
• Drive continuous improvement for the assigned SMS 2.0 areas as the Level 2 CI Specialist
• Provide coaching and guidance to Level 1 CI specialists to assure CI loop is delivering the desired performance and is aligned with the SMS 2.0 CI pillar standard
• Participate in the identification and prioritization of performance improvement initiatives on the shop floor
• Leading problem-solving sessions leveraging existing SMS tools as Gemba Problem Solving (GPS3)
• Serve as a GPS3 onsite expert to lead critical investigations
• Provide GPS3 training in support of SMS Upskilling Lead
• Coach departments/PCUs during investigations to establish embedded, self-sufficient GPS3 ways of working within the operational areas
• Being the OPEX method and training referent for his/her area and supporting M&S network (e.g., Maturity Assessment execution, SMS Trainer‚Ķ)
• Contribute to the SMS training program by being a certified trainer and by defining and supporting the SMS upskilling plan for the specific area
• Coordinate the preparation and execution of Maturity Assessments with the PCU, SMS Program Lead, and visiting Assessors
• Expert knowledge of SMS Standards to manage performance for specific area supported

Qualifications

• Bachelor‚Äôs degree in Engineering, Science, Business, or a related field, with 3+ years of experience in continuous improvement, manufacturing operations, or a related area. OR
• In lieu of a degree, 9+ years of relevant experience in continuous improvement, manufacturing operations, or a related field, with a demonstrated track record of career growth and progression.
• Strong knowledge and practical application of continuous improvement methodologies (e.g., Lean, CI, Manufacturing Excellence, SMS, etc.).

Preferred Qualifications

• Bachelor‚Äôs degree in Engineering, Science, Business, or a related field, with 10+ years of experience in manufacturing operations or operational excellence roles.
• SMS Intermediate certification or an equivalent Lean and/or Six Sigma certification from a recognized organization (e.g., AME, ASQ, LEI, LSSI).
• Proven experience applying continuous improvement methodologies such as Lean, CI, Manufacturing Excellence, SMS, or similar framework