Head of technical operations Job at Mantell Associates (Hamburg)

Job Description

Mantell Associates is partnered with a leading global CDMO, who is seeking a seasoned and German-speaking Head of Technical Operations 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.

Job Responsibility

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

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

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Head of technical operations

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