Director, Operational Excellence

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.

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.

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.

The responsibilities

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 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)
  • On-Time Delivery (OTD)

Required qualifications

• 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)

Preferred Qualifications

• 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)

Physical / safety requirements

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting or standing for long hours

In return, you’ll be eligible for

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.