Overview

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.Responsibilities

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.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 current Good Manufacturing Practices (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.Exhibiting "can-do" attitude, "out-of-the-box" thinking and good attention to details.Excellent verbal and written communication skills.Energetic individual, eager 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?

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.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.

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