Senior Manager Quality (GMP)
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Key Accountabilities:
- Become familiar withMoonLakesproducts technical agreements regulatorydossiersand subcontracted manufacturingsupplychain
- Maintain awareness of international GMP compliance requirements for InvestigationalMedicinal ProductsBiotech API and drug product manufacture including the GCP interface
- Become familiar with MoonLakesquality 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 assessmentand batch review
- Provide advice on GMP to client groupswithin MoonLakeproviding necessary oversight to ensure compliance
- Become familiar with MoonLakes drugproduct manufacture andpacked stock release procedures and ensureQPs are made aware of any compliance issues which couldimpactupon the safety of MoonLakesclinical products
- Provide QA support to validation activities at CMOs/CTOs
- Undertake other quality assurance duties as
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 productsis desirable
- Some knowledge of validation requirements within the Bio/Pharmaindustry
- 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.
- 2 days a week in our brand new Porto or Zug offices.
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.
MoonLake Immunotherapeuticsis 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 companys 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.
Required Experience:
Senior Manager
About Company
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 Glo ... View more
