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For Companies At a Glance
- Tasks: Lead the development and qualification of drug device combination products.
- Company: Join MoonLake, a dynamic biotech company transforming global healthcare.
- Benefits: Enjoy remote work options, career growth, and a supportive learning environment.
- Why this job: Make an impact in groundbreaking projects while collaborating with experienced professionals.
- Qualifications: Bachelor's in Biotechnology with 10+ years in pharma; leadership and regulatory experience required.
- Other info: Work hybrid in our new Cambridge or Zug offices, embodying our core values.
The predicted salary is between 60000 - 84000 £ per year.
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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Senior Technical Manager, Device employer: MoonLake Immunotherapeutics
Contact Detail:
MoonLake Immunotherapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Technical Manager, Device
✨Tip Number 1
Make sure to highlight your experience with drug device combination products in your conversations. Discuss specific projects where you successfully led teams or managed timelines, as this will demonstrate your capability as a Project Leader.
✨Tip Number 2
Familiarize yourself with the latest ISO standards and cGMP regulations. Being able to speak knowledgeably about these topics during interviews will show that you are well-prepared and understand the compliance landscape.
✨Tip Number 3
Network with professionals in the biotech industry, especially those who have experience with regulatory submissions in the US and EU. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 4
Prepare to discuss your approach to collaboration and relationship-building with both internal stakeholders and external vendors. Share examples of how you've successfully navigated complex projects through effective communication and teamwork.
We think you need these skills to ace Senior Technical Manager, Device
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Technical Manager, Device position. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in drug device combination products, particularly your track record with regulatory filings and project management. Use specific examples to demonstrate your expertise.
Showcase Leadership Skills: Since the role requires strong leadership, provide examples of how you've successfully led projects or teams in the past. Highlight your ability to drive results and collaborate effectively with internal and external stakeholders.
Tailor Your Application: Customize your cover letter to reflect MoonLake's core values. Discuss how your personal values align with their mission of innovation and excellence in healthcare, and express your enthusiasm for contributing to their impactful work.
How to prepare for a job interview at MoonLake Immunotherapeutics
✨Showcase Your Expertise
As a Senior Technical Manager, you need to demonstrate your deep understanding of drug device combination products. Be prepared to discuss your previous experiences in leading projects and how you ensured timely delivery of GMP DDC product batches.
✨Highlight Regulatory Knowledge
Since the role involves US and EU regulatory filings, make sure to highlight your experience with these processes. Discuss specific examples where you successfully navigated regulatory challenges during clinical trials or marketing applications.
✨Emphasize Collaboration Skills
This position requires strong collaboration with internal stakeholders and external vendors. Share examples of how you've built effective relationships and worked cross-functionally to achieve project goals.
✨Prepare for Technical Questions
Expect technical questions related to ISO standards, cGMP, and risk analysis. Brush up on these topics and be ready to discuss how you've applied this knowledge in your previous roles to drive results.
