Director, Operational Excellence

About the role

Simtra BioPharma Solutions is a world‑class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra offers a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization. Product types span biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – all injected directly into patients worldwide. The organization emphasizes quality and continuous improvement, holding itself to the highest cGMP and regulatory standards while also providing formulation development, lyophilization optimization, global regulatory support and secondary packaging.

Simtra 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. The Director, OpEx is a member of the site senior leadership team and reports to the Site Head.

Responsibilities

• 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; track and deliver impact based on measured KPIs.
• Lead and mentor a team of OpEx professionals, fostering a culture of accountability and high performance.
• Proactively identify opportunities to streamline manufacturing, quality, and other processes, reduce lead times, 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 the OpEx team has a strong presence on the shop floor to understand ground truth and drive initiatives on the front line, coaching operators and supervisors on the Simtra Production System.
• 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 the site.
• Develop and present reports on operational performance, key improvement initiatives, and strategic projects for senior management and clients.
• Analyze real‑time operational data to identify trends, deviations, and improvement opportunities.
• Collaborate with cross‑functional teams to design and implement corrective actions based on data insights.
• Ensure alignment of operational activities with strategic KPIs, including Right First Time (RFT) and On‑Time Delivery (OTD).

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Operations Management or related field.
• 10+ years of experience in pharmaceutical or similarly regulated manufacturing operations.
• 5+ years of experience in a people leadership role with a strong track record in operational excellence and performance improvement.
• Proven experience leading cross‑