Manufacturing Unit Head (m/w/d) PS4

Manufacturing Unit Head (m/w/d) PS4

Purpose

As a member of the Site Leadership Team, the Head of Manufacturing PS4 is accountable for overseeing the entire process of turning raw material into drug substance of established commercial products. The role focuses on ensuring operational excellence, continuous improvement, and the resilience of the supply chain, while maintaining the highest levels of safety and quality compliance.

Key Responsibilities

• Provide strategic leadership and manufacturing execution, taking full accountability for the drug substance production process, ensuring delivery, quality, and cost efficiency.
• Build and maintain a robust, flexible supply chain, lead a multi‑disciplinary team, and drive successful technical transfers and product launches.
• Shape the vision and long‑term strategies for the DS Production PS4 line, providing strategic advice to site leadership.
• Drive continuous improvement, implement Lean practices, and optimize manufacturing processes for efficiency and robustness.
• Ensure adherence to cGMP and quality standards, manage deviations, and maintain inspection readiness.
• Lead and develop a high‑performing, multi‑disciplinary team, fostering innovation and growth.
• Support and execute the introduction of new molecular entities and the successful technical transfer of products, ensuring timely and compliant market launches and regulatory compliance.
• Collaborate with internal and external stakeholders, including global network partners, to align on operational goals and initiatives.
• Ensure safety, manage budget, and optimize cost per gram as a key productivity metric.
• Take full ownership of drug substance production, including quality, delivery, and cost, managing a large team and budget; approximately 100 FTE and ~20 million euros.

Qualifications

• Education: BS/BA in life sciences, physical sciences, engineering, or an equivalent combination of education and experience; Master’s or PhD with 10–15 years of leadership experience; post‑graduate education or management training (e.g., MBA) highly desirable.
• Experience: Extensive experience in biopharmaceutical manufacturing, cross‑functional leadership, and proven success in end‑to‑end pharmaceutical business execution; deep understanding of cGMP, quality systems, and regulatory standards; expertise in Lean manufacturing and process optimization under stringent regulatory conditions; expertise in technical development and launch of new products.
• Skills: Strong leadership in the Visionary, Architect, Coach, Catalyst (VACC) model; ability to remove barriers and foster collaboration across Manufacturing Units; demonstration of applying Lean Manufacturing principles, enhancing operational efficiency, and driving continuous improvement; proven ability to build high‑performing, cross‑functional teams in complex, regulated environments; strong communication skills, including experience presenting to regulatory authorities; change management expertise with the ability to create a bold shared vision and lead teams through periods of uncertainty.