SMS Area Lead - Drug Product

Job Title: Continuous Improvement Specialist (Formulation, Filling, Inspection, & Packaging)

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Sanofi Manufacturing System (SMS) Area Lead serves as the Operational Excellence (OPEX) representative in a specific department (e.g., DS,  Filling, Packaging, QC, etc). This role is responsible for driving continuous improvement, supporting performance initiatives, driving the SMS maturity and leading problem-solving efforts using SMS tools.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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’s 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…)

• 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

About You

Required Qualifications

• Education & Work Experience: Bachelor’s degree in engineering, business, or related field w/ 5+ years of experience in manufacturing operations or operational excellence roles. In lieu of a bachelor’s degree, 12+ years of experience in manufacturing or operational excellence roles w/ demonstrated history of positive career progression. SMS Intermediate certification or equivalent lean and/or six sigma certification from reputable organization (AME, ASQ, LEI, LSSI, etc).

• Transformation and Change Management Skills: Knowledge of SMS/TPS/similar operating standards and operational excellence methodologies. Proven experience leading transformation initiatives and managing change.

• Technical Knowledge: Understanding of pharmaceutical manufacturing processes and regulatory requirements. Basic understanding of financial concepts including P&L, BOI, COGM, cash flow, and performance management systems. Solid understanding of data management & digital products embedded into the SMS operating standards.

• Analytical Skills: Advanced analytical capabilities for strategic decision-making and performance analysis. Experience with data-driven improvement methodologies and digital transformation initiatives.

• Project Management: Experience managing cross-functional programs and project portfolios. Ability to develop and execute strategic roadmaps across multiple workstreams.

• Coaching: Demonstrat