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Job Purpose
The Quality Specialist supports the Device and GMP Senior Quality Managers in providing Quality oversight of MoonLake’s manufacturing supply chain to ensure compliance with GMP, Device manufacturing requirements, MoonLake’s regulatory dossiers, and the release schedule. Provides necessary oversight to client groups on GMP compliance within MoonLake and CDMOs, with specific emphasis on tracking and review of deviations, changes, and manufacturing records. Collaborates effectively with the rest of the MoonLake Quality team and consultants to ensure seamless support to MoonLake functional groups.
Key Accountabilities
1. Become familiar with MoonLake products, technical agreements, regulatory dossiers, and subcontracted manufacturing supply chain.
2. Maintain awareness of international GMP compliance requirements relevant to MoonLake’s Drug-Product-Device combination products.
3. Become familiar with MoonLake’s quality systems, contributing to their maintenance and ongoing improvement.
4. Ensure GXP compliance of contractors for Drug Product manufacture and testing, working with the Senior Manager GMP Quality, and acting as the QA contact with CMO/CTO on set-up, deviations, change assessment, and batch review.
5. Ensure compliance of contractors for manufacture and testing of DP-device combination products, collaborating with the Senior Manager Device Quality.
6. Familiarize with MoonLake’s packed stock oversight and release procedures, ensuring QPs are aware of any compliance issues impacting clinical product safety.
7. Manage MoonLake’s internal review process for deviations and changes related to DP or device manufacture.
8. Undertake other quality assurance duties as required.
Your profile
Education:
* Scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry, or related).
Experience
* Experience in Quality functions within pharmaceutical/biotech or device manufacturing, especially in batch review and manufacturing oversight.
* Experience in sectors with similar Quality Systems (e.g., ISO9001) is also valuable.
Skills/Knowledge/Behavioral Competencies
* Basic understanding of biologics drug product and/or medical device compliance is desirable.
* Experience in aseptic manufacture of biologic drugs and/or medical devices is an advantage.
* Attention to detail and ability to work accurately in a busy environment.
* Effective written and verbal communication skills.
* Strong analytical and problem-solving skills.
* Self-motivated with proactive approach within a matrix team.
Work Location
* 2 days a week in our Cambridge or Porto Office(s).
Why us?
An exciting opportunity!
MoonLake is a dynamic, innovative company seeking passionate individuals to join our team.
What we offer:
* Learning environment with experienced professionals.
* Impactful projects in global healthcare.
* Flexible work options for work-life balance.
* Career growth and development opportunities.
Our Core Values
* We do Stellar Science: Creating novel therapies with high quality and innovation.
* We go beyond: Challenging norms and being positively disruptive.
* We unlock value: Creating long-term value for investors and communities.
About us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company developing sonelokimab, a novel Nanobody for inflammatory diseases.
Founded in 2021, headquartered in Zug, with hubs in Cambridge & Porto. More info at www.moonlaketx.com
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