Director (m / f / x) Manufacturing

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.

At our plants in Halle / Westphalia and Bloomington / Indiana, we produce drugs for the treatment of various cancers and other life-threatening disease.

In the role as a Director (m / f / x) Manufacturing you´ll lead and manage a team of 350+ professionals across production, visual inspection, and packaging operations. You will be empowered to :

• Oversee end-to-end pharmaceutical manufacturing processes, ensuring timely, cost-efficient, and GMP-compliant production of parenteral drugs
• Direct all production-related activities, including strategic planning, organization, and monitoring of processes to meet quality and regulatory standards
• Drive team development through coaching, performance management, and talent acquisition, including onboarding and integration of new hires
• Develop and implement optimized production strategies, continuous improvement initiatives, and efficiency-enhancing guidelines
• Taking immediate corrective actions as “Head of Production” under AMG regulations during pharmaceutical law-related incidents to ensure uninterrupted and compliant delivery
• Ensure Right-First-Time mindset in all areas of responsibility
• Ensure strict adherence to occupational safety standards, particularly in handling hazardous substances
• Represent the production function in cross-functional collaboration with logistics, planning, controlling, quality assurance / control, business management, and operational excellence teams

What you'll bring :

5–10 years of proven success in operations management within a high-performance, fast-paced production environment

Extensive experience in aseptic pharmaceutical manufacturing; background in cytostatic drug production and lyophilization processes strongly preferred

Solid track record in establishing, scaling, and optimizing production lines to meet strategic and regulatory objectives

Ability to lead and inspire large teams while ensuring compliance and operational excellence

Confident, resilient, and results-driven with high energy and a proactive mindset

Strong interpersonal, communication, and collaboration skills

Strategic thinker with hands-on leadership and expertise in change management

Highly organized, analytical, and detail-oriented with the ability to inspire and influence

Benefits :

We offer interesting opportunities to committed and talented people. Gender, age, skin color, origin, sexual orientation and disabilities do not play a role - on the contrary : we promote diversity and believe that diversity is an enrichment.

We look forward to receiving the documents relating to your professional career directly via our online system.

If you have any questions, please contact Codrina Schech (Consultant) (cschech@simtra.com).

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