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Head of technical operations

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Mantell Associates

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Location:
Germany , Hamburg

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

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

Additional Information:

Job Posted:
December 10, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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