Monoclonal Antibody Technical Lead

The mAb Technical Lead will provide technical oversight of late-phase monoclonal antibody manufacturing activities performed by external CDMO partners. The role will ensure that manufacturing testing release and supply activities are appropriately planned and executed to maintain timely and reliable clinical supply.

Working cross-functionally with Clinical Development Regulatory Affairs Quality Supply Chain and external CDMO partners the mAb Technical Lead will identify and manage technical and supply risks coordinate key deliverables and timelines and support continuous product availability for ongoing and planned clinical studies.

Your tasks:

• Provide technical oversight of late-phase monoclonal antibody GMP manufacturing testing batch release and product resupply performed by external CDMO partners.

• Act as the technical point of contact for external CDMO partners on manufacturing product quality process performance and process optimization as required and manage CDMO deliverables and governance interactions.

• Coordinate manufacturing and supply plans including material availability production slots testing release and delivery to meet clinical demand.

• Manage the project budget and timelines including budget planning expenditure tracking and monitoring progress against agreed milestones.

• Contribute technical and manufacturing information to CMC regulatory submissions and responses to health authority questions.

• Identify assess and manage technical quality timeline and supply risks and drive appropriate mitigation and contingency plans.

• Collaborate closely with Clinical Development Quality Regulatory Affairs and Supply Chain to align manufacturing and supply activities with clinical priorities.

• PhD in Biochemistry Biotechnology Chemical Engineering Pharmaceutical Sciences Immunology or a related discipline.

• Minimum 5 years of relevant industry experience in biologics manufacturing and CMC with significant experience in monoclonal antibodies.

• Demonstrated experience supporting late-phase activities including GMP manufacturing testing batch release and clinical supply.

• Strong understanding of E2E late-phase biologics manufacturing and process lifecycle management (i.e. upstream and downstream processing analytical testing product characterization and stability programs formulation drug product manufacturing and clinical supply requirements GMP manufacturing testing batch release and quality systems technology transfer process validation regulatory CMC requirements).

• Proven experience managing CDMOs and external manufacturing partners including governance performance timelines and issue escalation.

• Strong scientific problem-solving risk management and project leadership skills with the ability to translate technical issues into pragmatic actions.

• Fluent in written and spoken English; additional languages are a plus.

• Strong communication and stakeholder management capabilities combined with an agile hands-on mindset and the ability to adapt priorities and operate effectively in a fast-paced biotech environment.

• This is a fixed-term position and will end on December 31 2029.

• Work location: on site in Allschwil with up to 2 days home office.

Candidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland.

If you meet most of these requirements and bring a strong dedication to mAb development we encourage you to apply. You will contribute directly to our mission of advancing new medicines for patients.