Technical Lead for Device Development

1 month ago


Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

We are MoonLake Immunotherapeutics, a biotech company that aims to transform global healthcare with novel therapies. We offer an exciting opportunity for a Technical Lead for Device Development to join our team.

Job Description

The Senior Technical Manager, Device will act as the subject matter expert responsible for all activities related to the development and PPQ (process performance qualification) for assembly of drug device combination product (DDC), functional testing of DDC to supply clinical studies and launch/commercial phase, as well as review and update the dossier in support of the required submissions for clinical use and commercial launch.

  • Act as Technical Subject Matter Expert for DDC related topics
  • Lead technical projects to define and drive deliverables and ensure timely delivery of GMP DDC product batches
  • Manage the creation and review of relevant device design documents required for the Design History File and General Safety Performance Requirements for each presentation of the DDC product (autoinjector, needle safety device)
  • Ensure successful Human Factor studies for each presentation of the DDC product (autoinjector, needle safety device)
  • Establish strong relationships and efficient collaboration with Contract Manufacturing Organizations (CMOs)
  • Ensure PPQ is successfully achieved and ready for commercial launch
  • Review and/or approve batch documentation, validation-related activities, risk/gap analysis, protocols, and reports
  • Develop and manage stability plans and review data to support product shelf-life and extreme conditions
  • Support technical decision making, trend analysis, and root cause investigations within a timely manner to avoid potential delays and/or interruption to supply
  • Contribute to quality, supply, innovation, and cost aspects for DDC
  • Support regulatory submissions and responses to Health Authority questions/requests
  • Partner with internal stakeholders to support drug product production, clinical development, product supply/transport activities
  • Support intellectual property strategy and filings where DDC subject matter expertise is needed
Required Skills and Qualifications

We seek a highly skilled professional with a Bachelor of Science degree in Biotechnology or a relevant discipline and a minimum of 10 years of pharmaceutical industry experience.

  • Proven track record for partnering internally and externally to deliver drug device combination product milestones on-time and right first time, across the phases of clinical development through commercialization
  • Experience with US and EU regulatory filings for clinical trial and/or marketing applications
  • Demonstrated leadership to drive results that are required to achieve the company's goals

Candidates should possess excellent communication, project management, collaboration, and organizational skills, with a strong working knowledge of ISO standards, current Good Manufacturing Practices (cGMP), and regulatory requirements.

Estimated Salary

The estimated salary for this position is between $150,000 and $200,000 per year, depending on location and experience.

Why Join Us?

MoonLake Immunotherapeutics offers a dynamic work environment, flexible working arrangements, and opportunities for career growth and development.



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