Director, Operational Excellence

Simtra BioPharma Solutions•Bloomington, IN

6h•Onsite

About The Position

Simtra BioPharma 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 at Simtra. We 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. This role: 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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Operations management or related field
10+ years of experience in pharmaceutical or similarly regulated manufacturing operations with 5+ years of experience in a people leadership role, with a strong track record in operational excellence and performance improvement
Proven experience in leading cross-functional teams and driving change in high-complexity environments
Excellent communication and stakeholder engagement skills
Proficiency in Microsoft 365 (Word, Excel, Powerpoint, Outlook) and the ability to use enterprise and AI software (e.g., D365, SAP, TrackWise, ServiceNow, Veeva, Claude, ChatGPT)

Nice To Haves

Master’s Degree equivalent or higher
Strong knowledge of sterile manufacturing processes and regulatory requirements (FDA, cGMP, etc.)
Experience with software such as Quality Management Systems, ERPs, OT
Lean Six Sigma Green Belt or Black Belt
Strong analytical skills with proficiency in data visualization and performance reporting tools (e.g., Power BI, Tableau, Excel)
Project Management Professional (PMP)

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 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
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
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)