The 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 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.

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.

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.
Workplace: 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.

Contact

Doris Fink
Recruiter
Alentis Therapeutics AG

Monoclonal Antibody Technical Lead

Tasks

Requirements

Contact