Director, Operational Excellence

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

Simtra Biopharma Solutions is seeking a dynamic and experienced Director of Operational Excellence (OpEx) to lead performance improvement initiatives across the Bloomington site partnering with manufacturing, quality, and supporting departments. This role is pivotal in driving operational discipline, lean execution, and data-informed performance management to ensure consistent, high-quality production and timely delivery of life-saving pharmaceutical products. The Director, OpEx is a member of the site senior leadership team, and reports to the Site Head.

Leadership and Strategy:

• Work with at-site, above-site, and cross-site leadership to develop the Simtra Production System based on Lean Six Sigma principles
• Champion Simtra Production System principles across the site to power stable, predictable, high-quality operations and instill a culture of continuous lean improvement
• Develop and execute annual OpEx objectives, kaizens, and projects and track and deliver impact based on measured KPIs
• Lead and mentor a team of OpEx professionals, fostering a culture of accountability and high performance

Process Improvement and Lean Execution:

• Proactively identify opportunities to streamline manufacturing, quality, and other processes, reduce lead times, and enhance overall efficiency, increase capacity, or reduce costs.
• Oversee the execution of continuous improvement initiatives and Kaizens, ensuring alignment with client and regulatory requirements and quality standards
• Ensure that the OpEx team has a strong presence on the shop floor to both understand the ground truth on the floor and drive initiatives on the front line, helping to coach operators and supervisors on the Simtra Production System

Performance Management and Reporting & Analytics

• Work with digital teams to develop and maintain performance dashboards and executive scorecards tailored to business and operational needs
• Build, maintain, and roll out management infrastructure best practices such as tier meetings, visual management, and leader standard work across…