Head of GMP Manufacturing (all genders)

The Head of Manufacturing is responsible for the strategic leadership and operational day to day management of all manufacturing activities, utilities and systems and in accordance with applicable regulatory requirements and internal quality standards at the site in Taufkirchen near Munich, Germany. The position holder will be part of the site leadership team.

Key Responsibilities:

• Lead and direct the GMP Manufacturing department overseeing drug product manufacturing, including process development, scale-up, technology transfer, formulation operations, and GMP production
• Provide technical leadership and mentorship to cross-functional teams and ensure alignment of technical strategy with production capabilities
• Drive continuous improvement of processes, yield, cost of goods, throughput, and capacity utilization by implementing robust process optimization and lean manufacturing principles
• Ensure reliable execution of technology transfers to/from Munich site, enabling smooth handoffs from R&D / development labs into GMP manufacturing
• Oversee technical troubleshooting, deviations, and root cause investigations; proactively address performance bottlenecks, equipment or facility constraints, and process drift
• Maintain regulatory and GMP compliance (EU GMP, EMA, German regulatory bodies) in all operational and technical activities; ensure site readiness for audits and inspections
• Collaborate closely with Supply Chain, Quality Assurance, Regulatory Affairs, and Commercial teams to support product launch readiness and client commitments

Essential Criteria:

• Master`s degree or PhD in a scientific or engineering discipline 
• Minimum of 10 years of experience in commercial or clinical manufacturing operations, including at least 5 years in a leadership role in a CDMO or (Bio)Pharma environment
• Knowledge of Advanced Therapies Medical Products (ATMP’s) preferred 
• Extensive knowledge of GMP and EMA regulations, experience with individual products preferred
• Strong leadership and management skills, with a demonstrated ability to lead cross-functional teams
• Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders
• Experience managing budgets and financial performance
• Fluent in German (spoken and written) to lead teams locally; Fluent in English
• Willingness for on-site presence in Munich, German

Minaris Regenerative Medicine GmbH ist ein globaler Partner für Auftragsforschung und Lohnherstellung. Wir produzieren hochmoderne Zell- und Gentherapien nach den Vorgaben der Guten Herstellungspraxis (GMP) für die Anwendung im Menschen. Bei uns tragen Sie aktiv zum medizinischen Fortschritt bei und geben schwer kranken Patienten Hoffnung.