Job Purpose
As an Associate Manager, Analytics Technical Operations, you are responsible for supporting the oversight and management of the history, validation and implementation of analytical test methods that support characterization, stability and batch release testing for Phase II/III clinical trials, BLA preparation and post-marketing.
Main Accountabilities:- Support the oversight, management and review of third-party vendor activities, with accountability for technical approaches, compliance with current regulatory and industry standards, study level timeliness and quality.
- Support and technically contribute to the further development of methods for MoonLake’s proprietary trivalent Nanobody® sonelokimab.
- As appropriate to outsourced cGMP biologics manufacture, ensure CMC Analytical Development records, documentation and vendor reports support regulatory inspections and submissions. Ensures the delivery of high-quality CMC sections for IND/CTA/BLA filings.
- Act as contact for CMC analytics vendors to ensure effective communication between MoonLake and all external vendors.
- Communicate progress and identify risks and issues arising to the Director, Analytics Technical Operations and other MoonLake development team members as appropriate.
Your profile
Education: Bachelor of Science degree in relevant scientific discipline.
Experience:- 5+ years of experience in the pharmaceutical/biotech industry of CMC analytics for the clinical development of biological therapeutics.
- Experience of managing outsourced activities at cGMP vendors.
Skills/knowledge/behavioural competencies:- Experience in the development and validation of analytical methods to support in-process and release testing of biologics. Robust knowledge of cGMP and related regulatory standards for CMC analytics.
- Sound understanding of Critical Quality Attributes principles.
- Excellent oral and written communication skills.
- Highly organised, able to prioritise work, work well under pressure and meet deadlines.
- Independent, self-starter with a proactive, problem solving approach.
- Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
Work Location: 2 days a week in our brand new Cambridge, Porto 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.
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
