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.

Why join Team Simtra Because we:

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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.

Theresponsibilities:

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:

Bachelors 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:

Masters 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 youll be eligible for1:

• Day One Benefits
  • 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.

Equal Employment Opportunity

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.

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Director