The Chemist / Conjugation Expert acts as SME for the development, optimization, and scale-up of bioconjugation processes for our antibody-based therapeutic portfolio. As a key technical contributor, you will define conjugation strategies, establish critical process parameters and appropriate process controls, and support product and process characterization to ensure robust, reproducible, and scalable manufacturing of the payloads and ADCs. With your technical expertise, you will supervise programs from R&D through clinical development, including technology transfer and GMP manufacturing readiness, while working closely with internal CMC, Quality, and Regulatory functions. The role includes oversight of technical activities performed by CDMOs and other external partners, troubleshooting of process-related issues, and contribution to CMC documentation and regulatory submissions.

Tasks

Lead the development, optimization, characterization, and scale-up of robust and reproducible antibody conjugation processes, from early development through clinical manufacturing.
Serve as the subject matter expert for conjugation chemistry and process development, providing scientific guidance, reviewing technical data, and leading troubleshooting and root-cause investigations for process-related issues.
Collaborate with the CMC Lead and the Quality manager to establish appropriate analytical control strategies and support product characterization, comparability assessments, stability studies, and investigations.
Define critical process parameters, process controls, and scale-up strategies, and support technology transfer, process validation readiness, and GMP manufacturing activities at external manufacturing sites.
Manage technical interactions with CDMOs and external development partners, including preparation and review of development plans, protocols, reports, batch documentation, technical proposals, timelines, and deliverables.
Contribute to CMC development strategies and author or review relevant technical documentation for regulatory submissions, responses to health authority questions, and internal governance reviews.

Requirements

PhD in Chemistry, Chemical Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, with a strong foundation in protein chemistry and bioconjugation.
At least 5 years of relevant industry experience in bioconjugation, process development, or CMC development of AxCs products including site-specific conjugation technologies, linker-payload chemistry, or other complex bioconjugate modalities
Demonstrated expertise in bioconjugation chemistry and antibody-related technologies, including reaction optimization, purification, and characterization of conjugated products.
Hands-on experience in process development, scale-up, technology transfer, and technical support of manufacturing activities, preferably involving external partners or CDMOs.
Good understanding of GMP requirements and experience supporting clinical-stage development, including preparation or review of technical and CMC documentation.
Strong scientific communication, problem-solving, and project leadership skills, with the ability to work effectively across functions and manage technical activities with external partners.
Fluent in written and spoken English; additional languages are a plus.
A flexible, agile, and hands-on mindset, with the ability to adapt priorities and operate effectively in a fast-paced biotech environment.
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