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.
In charge of defining and aligning the analytical control strategy across departments (e.g. Regulatory Affairs, CMC, Quality). 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