Job Purpose
The Senior Technical Manager Drug Substance serves as the technical leader and subject matter expert responsible for drug substance development, control strategy, transfers, GMP manufacturing and supply from CDMOs in support of MoonLake’s global clinical development programs.
Major Accountabilities- Acts as Technical Subject Matter Expert for all Drug Substance related topics to all internal and external stakeholders.
- Acts as a Project leader to define and drive technical deliverables and ensure timely delivery of GMP drug substance according to overall project plan.
- Ensures strong relationship and efficient collaboration with CMOs.
- Ensures success for dossier ready process (DS manufacturing and Analytics).
- Reviews and approves Master batch records, development and validation risk analysis, protocols and reports.
- Analyses/interprets development data to support technical decision making, trend analysis, and root cause investigations.
- Provides support on quality, supply, innovation and cost aspects in the field of Drug Substance.
- Supports the DS sections of the regulatory submission documents.
- Effectively partners with internal stakeholders to support drug product activities.
- As needed, evaluate and select drug substance manufacturing partners aligned with supply chain strategy and contribute to intellectual property strategy and filings where drug substance subject matter expertise is required.
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
