Senior Technical Manager

1 month ago


Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Job Summary

We are seeking a highly skilled Senior Technical Manager to lead our device development efforts. As a key member of our team, you will be responsible for ensuring the successful development and qualification of our drug device combination products.

Key Responsibilities
  • Act as the subject matter expert for device-related topics, providing technical guidance and support to cross-functional teams.
  • Lead the development of technical deliverables, ensuring timely delivery of GMP-compliant product batches.
  • Manage the creation and review of device design documents, including the Design History File and General Safety Performance Requirements.
  • Ensure successful Human Factor studies for each device presentation.
  • Develop and maintain strong relationships with Contract Manufacturing Organizations (CMOs).
  • Oversee the qualification process to ensure commercial launch readiness.
  • Review and approve batch documentation, validation activities, risk/gap analysis, protocols, and reports.
  • Manage stability plans and review data to support product shelf-life and extreme conditions.
  • Support technical decision-making, trend analysis, and root cause investigations.
  • Contribute to quality, supply, innovation, and cost aspects for drug device combinations.
  • Support regulatory submissions and responses to Health Authority questions and requests.
  • Collaborate with internal stakeholders to support drug product production, clinical development, and product supply/transport activities.
Requirements
  • Bachelor of Science degree in Biotechnology or relevant discipline with a minimum of 10 years of pharmaceutical industry experience.
  • Proven track record of partnering internally and externally to deliver drug device combination product milestones on-time and right first time.
  • Experience with US and EU regulatory filings for clinical trial and/or marketing applications.
  • Demonstrated leadership to drive results that achieve the company's goals.
What We Offer
  • A learning environment that fosters growth and innovation.
  • The opportunity to contribute to groundbreaking projects that transform global healthcare.
  • A flexible work arrangement that balances work and life.
  • A clear path for career progression and professional development.

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