Senior Quality Expert (GMP)

Job Purpose
A Senior Quality Expert (Good Manufacturing Practices) will provide oversight of MoonLake's manufacturing supply chain to ensure compliance with GMP, MoonLake’s regulatory dossiers and the release schedule, provide advice, support and the necessary oversight to client groups on GMP compliance within MoonLake and collaborate effectively with rest of the MoonLake Quality team and consultants, representing Quality on specific project teams.
Key Accountabilities

• Become familiar with MoonLake products, technical agreements, regula-tory dossiers, product specification files and subcontracted manufacturing chain
• Maintain awareness of international GMP compliance requirements for investigational products Biotech API and drug product manufacture including the GCP interface
• Become familiar with Moonlake's quality systems (contributing to their maintenance and ongoing improvement)
• Ensure GXP compliance of contractors for API manufacture and testing, taking responsibility for QA contact with CMO/CTO on set-up, deviations and change assessment and batch review
• Provide advice on GMP to client groups within Moonlake providing necessary oversight to ensure compliance
• Become familiar with MoonLake's drug product manufacture and packed stock release procedures and ensure QPs are made aware of any compliance issues which could impact upon the safety of Moonlake's clinical products
• Provide QA support to validation activities at CMOs/CTOs
• Undertake other quality assurance duties as required
  

Your profile
Education: Scientific degree (ideally pharmacy, pharmaceutical sciences, Biology, chemistry or related
Experience: Demonstrable track record and skills/experience gained in Quality functions in multinational pharmaceutical/biotech environment, specifically in Batch review/manufacturing oversight
Skills/knowledge/behavioural Competencies

• Good understanding of Biologics Drug Substance manufacturing process
• Some experience in Aseptic manufacture of Biologic DP and/or combination products is desirable
• Some knowledge of validation requirements within the Bio/Pharma industry
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Self-motivated, with the ability to work proactively using own initiative
• Audit skills would be an advantage but not essential for this role
  

Work Location:

• 2 days a week in our brand new Porto or Cambridge office
  

Why us?
An exciting job opportunity awaits you!
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.
About Us
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com