Monoclonal Antibody Technical Lead

Alentis Therapeutics; Allschwil; Hybrid; CHF 180.000 - 210.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Zusammenfassung

Alentis Therapeutics in Basel-Landschaft, Allschwil seeks an mAb Technical Lead to oversee late-phase monoclonal antibody manufacturing with external partners. You will coordinate supply plans and govern CDMO deliverables with cross-functional teams to ensure continuous clinical supply.

You will manage budgets, timelines, and contribute to CMC regulatory submissions while identifying risks and implementing mitigation strategies in a fast-paced biotech setting.

Qualifikationen

• PhD in a Biochemistry/Biotechnology/Engineering or related field.
• Minimum 5 years in biologics manufacturing and CMC.
• Experience supporting late-phase activities: GMP manufacturing, testing, batch release, clinical supply.
• Fluent in English; other languages a plus.

Aufgaben

• Provide technical oversight of late-phase mAb GMP manufacturing with external CDMO partners.
• Act as technical contact for CDMOs on manufacturing, quality, and process optimization.
• Coordinate manufacturing and supply plans to meet clinical demand.
• Manage project budgets, timelines, and milestones.
• Contribute technical data to CMC regulatory submissions and responses.
• Identify and mitigate technical, quality, and supply risks.
• Collaborate with Clinical Development, Quality, Regulatory Affairs, and Supply Chain.

Kenntnisse

Project leadership

Risk management

Cross-functional collaboration

Scientific problem solving

English proficiency

Ausbildung

PhD in Biochemistry/Biotechnology/Chemical Engineering/Pharmaceutical Sciences/Immunology

Tools

GMP manufacturing

CMC knowledge

Process validation

Jobbeschreibung

About this position

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.

Role requirements

• 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.

Work permit

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

Your path forward

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.