Director, Plant Manager Building C

About Simtra BioPharma Solutions

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, small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, and vaccines—all directly injected into patients worldwide. We hold ourselves to the highest quality and regulatory standards, with a strong emphasis on quality and continuous improvement.

While our primary focus is cGMP manufacturing, we offer 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 Simtra?

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding expectations.
• Make it TOGETHER – We work as one, respecting each voice and leveraging unique strengths across teams to solve problems innovatively.
• Make it RIGHT – We uphold high standards of excellence, fulfilling commitments to customers, patients, and team members.
• Make it COUNT – We take pride in our work, knowing the impact we make in improving patient health through daily challenges.

Responsibilities

Strategic Leadership

• Provide strategic direction and leadership for all manufacturing functions.
• Develop, implement, and execute business strategies supporting 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.

Manufacturing Operations

• 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.

People Leadership

• 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.

Financial Management

• 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.

Continuous Improvement

• 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.

Cross-Functional Collaboration

• 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.

Requirements

• Bachelor’s 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.

Skills

• 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.

Benefits

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

Current benefit offerings are in effect through 12/31/26.