Senior Technical Manager Drug Substance

Overview

Senior Technical Manager Drug Substance at MoonLake Immunotherapeutics (NASDAQ: MLTX). This role acts 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 internal and external stakeholders.
• Acts as Project leader to define and drive technical deliverables and ensure timely delivery of GMP drug substance according to the overall project plan.
• Maintains strong relationships and efficient collaboration with CMOs.
• Ensures success for dossier-ready processes (DS manufacturing and Analytics).
• Reviews and approves Master batch records, development and validation risk analysis, protocols and reports.
• Analyzes/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 regulatory submission documents.
• Partners with internal stakeholders to support drug product activities.
• Evaluates and selects drug substance manufacturing partners aligned with supply chain strategy and contributes to intellectual property strategy and filings where drug substance subject matter expertise is required.

Your profile

Education: Bachelor/Master of Science in Biotechnology or relevant discipline.

• Experience:

• Minimum of 10 years’ experience in operations/manufacturing/external supply operations in the pharmaceutical/biotechnology industry.
• Proven track record for partnering internally and externally to deliver Drug Substance development milestones on-time and right-first across the phases of clinical development through commercialization.
• Experience in oversight of external supply organisations.
• Experience with US and EU regulatory filings for both clinical trial and marketing applications.

• Skills/knowledge/behavioural competencies:

• Subject Matter Expert in large molecule Drug Substance development and commercialization process.
• Strong working knowledge of cGMP and regulatory requirements.
• Able to collaborate in hands-on environment across technical fields of expertise.
• Excellent communication, project management, collaboration and organizational skills.
• Ability to develop strong relationships with external vendors and internal stakeholders.
• Can-do attitude, out-of-the-box thinking and attention to details.
• Excellent verbal and written communication skills.
• Energetic, able to manage multiple activities and priorities.
• Dedication to quality in all work tasks and deliverables in a timely manner.
• Impact-driven mindset.

Work Location

• 2 days a week in our Cambridge or Zug Office(s).

Why us?

MoonLake is a dynamic and innovative company pushing the boundaries of possibility. 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 opportunities to take on more responsibilities as you develop your skills.

Our Core Values

We look for MoonLakers who embody three core values that drive our pursuit of excellence:

We do Stellar Science: We aspire to create novel therapies with innovative science, high quality, always.

We go beyond: We aspire to be positively disruptive and bold in challenging norms.

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 inflammatory disease. We focus on inflammatory diseases with major unmet needs, including hidradenitis suppurativa and psoriatic arthritis. MoonLake was founded in 2021 and is headquartered in Zug, with hubs in Cambridge & Porto. Further information is available at www.moonlaketx.com

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science

Industries

• Biotechnology