Director, Plant Manager Building C

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:

The Plant Manager is responsible for providing strategic and operational leadership across manufacturing operations. This role oversees commercial manufacturing and continuous improvement initiatives. The position is accountable for achieving operational excellence regulatory compliance product quality employee engagement and business profitability. As a key member of the plant leadership team this individual drives plant-wide strategy fosters cross-functional collaboration and ensures alignment between customer demand manufacturing capabilities and business objectives.

The responsibilities:

• Provide strategic direction and leadership for all manufacturing functions.
• Develop implement and execute business strategies that support operational quality customer service financial and growth objectives.
• Serve as a member of the plant leadership team and drive plant-wide strategic initiatives.
• Lead organizational transformation and continuous improvement efforts across plant operations.
• Establish and monitor key performance indicators related to safety quality delivery cost and profitability.

• Direct all commercial manufacturing operations including aseptic filling packaging and production activities.
• Ensure operational performance meets production schedules budgets and customer requirements.
• Drive improvements in product quality operational efficiency and cost performance.
• Ensure compliance with current Good Manufacturing Practices (cGMP) EHS requirements and applicable regulatory standards.
• Participate as a subject matter expert during regulatory and customer audits.
• Resolve complex operational challenges requiring cross-functional collaboration and sound business judgment.

• Lead develop and mentor managers supervisors and operations leaders.
• Build high-performing teams through effective hiring coaching talent development succession planning and performance management.
• Establish performance objectives and support employee development plans.
• Foster a culture of accountability engagement safety continuous learning and operational excellence.

• Develop and manage operating budgets and long-range business plans.
• Ensure manufacturing activities align with financial objectives.
• Identify opportunities to improve profitability through operational improvements productivity gains and optimization.

• Champion Lean Manufacturing principles across the organization.
• Lead and sponsor continuous improvement initiatives including Kaizen events value stream mapping visual management problem-solving methodologies and process optimization.
• Utilize data and analytics to identify opportunities for operational enhancements and strategic decision-making.
• Promote a culture focused on waste elimination process standardization and sustainable performance improvements.

• Build strong partnerships with Quality Engineering Maintenance Technical Services Supply Chain Human Resources Finance and Commercial organizations.
• Lead cross-functional initiatives to support customer expectations new product introductions operational improvements and strategic business goals.
• Communicate critical business issues and opportunities to senior leadership and executive stakeholders.

• Bachelors degree in Business Supply Chain Management Engineering Operations Management or a related field required.
• MBA strongly preferred.
• APICS CPIM CSCP or similar professional certification preferred.

• Minimum of 10 years of progressive leadership experience in manufacturing or operations within a regulated manufacturing environment.
• Minimum of 5 years leading leaders including managers and senior-level functional leaders.
• Experience in contract manufacturing pharmaceutical biotechnology medical device or other highly regulated industries preferred.
• Demonstrated success managing large-scale manufacturing operations.

• Strong knowledge of cGMP regulations and global regulatory requirements.
• Extensive understanding of manufacturing processes and production systems.
• Advanced Lean Manufacturing and Continuous Improvement experience.
• Strong financial acumen including budgeting forecasting and cost management.
• Excellent leadership communication organizational and change management skills.
• Ability to influence cross-functional teams and lead through organizational complexity.
• Proficiency in Microsoft Office Suite and enterprise systems such as ERP quality management and manufacturing systems (e.g. JDE TrackWise Pilgrim SAP Oracle or similar platforms).

Physical / safety requirements:

• Duties may require overtime work including evenings weekends and occasional holiday coverage.
• Ability to use hands and fingers to operate office and manufacturing-related equipment.
• Position requires periods of sitting walking standing and facility floor presence.
• Ability to meet applicable manufacturing area gowning and safety requirements.
• Ability to work in both office and manufacturing environments.

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