Represent analytics in interdisciplinary teams and act as single point of contact for the CMC team and all relevant stakeholders
Ensure successful management of all analytical activities and actively report the status (progresses, delays, risks) to the relevant (cross-functional) stakeholders
Coordination of analytical tasks within the internal analytical network and external partners in line with the overall analytical strategy
Define and align the analytical control strategy across departments (e.g. Regulatory Affairs, CMC, Quality) and also ensure that the proposed strategy is in line with health authority guidelines and regulatory requirements
Take full ownership of the analytical CMC Module 3 package (authoring, review, lifecycle management)

An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable) optional PhD or equivalent qualification
Industry experience (10+ years) within biotech or pharmaceutical industry, strong background in analytical CMC activities for mAbs and/or work experience in mAb QC and/or analytical development
Proven track record in analytical late‑stage antibody development, ideally including antibody‑drug conjugates (ADCs)
Demonstrated leadership and analytical project management experience
Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, CMC analytical development packages, Good Manufacturing Practices, as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
Experience with pre‑approval activities (e.g. PAI, BLA preparation, launch activities) is a plus
Fluent English and technical writing skills
Experience in working in intercultural, cross-functional teams
Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
Highly motivated and willingness to work in a fast-paced and fast-evolving environment

Director AS&T Projects – Strategy

Key skills