Head of Engineering

Mantell Associates is partnered with a leading global CDMO, who is seeking a seasoned and German-speaking Head of Engineering for its Hamburg site.

In this high-impact role, you will lead the technical operations function for drug product manufacturing, ensuring that production, process engineering, scale-up, and tech transfer deliver excellence in quality, efficiency, and GMP compliance.

Head of Engineering - Responsibilities

• Lead and direct the Technical Operations 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 (Manufacturing, Process Engineering, Quality, MSAT) 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 Hamburg 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

Head of Engineering - Requirements

• Deep experience having worked in a CDMO environment, ideally leading technical operations or similar senior operational roles for drug product manufacturing
• Strong background in drug product (finished dosage forms - sterile or non-sterile) manufacturing operations, process development, and scale-up
• Excellent technical, scientific, and engineering problem-solving skills; able to lead tech transfer, manufacturing troubleshooting, equipment qualification/validation, and process optimization
• Fluent in German (spoken and written) to lead teams locally and interact with global stakeholders
• Demonstrated leadership experience managing sizeable technical/operations teams, driving operational metrics, and ensuring throughput, quality, GMP compliance, and cost performance
• Based in or able to relocate to Hamburg, Germany, with willingness for hybrid on-site presence

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0) .

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