Senior Technical Manager, Device

3 days ago

Cambourne, United Kingdom Moonlake Immunotherapeutics Full time

Job Purpose 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.
Main Accountabilities: Act as Technical Subject Matter Expert for DDC related topics Act as a Project leader to define and drive technical 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 a successful Human Factor study for each presentation of the DDC product (autoinjector, needle safety device) Ensure strong relationship and efficient collaboration with 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 Manage stability plan and review of 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 Support quality, supply, innovation and cost aspects for DDC Support the DDC regulatory submissions and responses to Health Authority questions / requests Effectively partner with internal stakeholders to support drug product production, clinical development, product supply / transport activities Support and/or contribute to intellectual property strategy and filings where DDC subject matter expertise is needed Your profile Education: Bachelor of Science degree in Biotechnology or relevant discipline with a minimum of 10 years of pharmaceutical industry experience.
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 Skills/knowledge/behavioural competencies: Subject Matter Expert in large molecule drug product manufacturing, commercialization process and ideally some knowledge with device Strong working knowledge of ISO standards, current Good Manufacturing Practices (cGMP) and regulatory requirements Able to collaborate in hands-on environment across technical fields of expertise Excellent communication, project management, collaboration and organizational skills Ability to develop strong relationships with external vendors and internal stakeholders Impact driven mindset Ability and willingness to travel Work Location: 2 days a week in our brand new Cambridge or Zug office(s) Why us?
An exciting job opportunity awaits
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.
What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values: We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
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