We are looking for a senior Drug Substance Project Leader in TD-NBE, to develop and drive technologies in the field of Gene Therapies.
The candidate will be accountable for general and strategic Drug Substance (DS) process aspects in this area. The role comprises the scientific leadership as the DS process expert in the project team as well as facilitation and tracking of major process development and manufacturing activities to ensure timely and consistent process development for Gene Therapy projects.
Within the CGT field, the candidate will build and establish expertise in viral vector process development and manufacturing with focus on upstream technologies.
DS process and technology strategy for Gene Therapy projects in early phase development, with focus on viral vector based Gene Therapies
Single point of contact for Project Technical Representatives and other stake holders for key DS process aspects
Planning and tracking of major DS process development and manufacturing activities and deliverables in collaboration with the Line Function
Represent the DS subteam as core member in the technical CMC project team
Coordinate and provide input to Reg-CMC on DS processes (e.g. in response to questions from regulatory authorities, Briefing Books, preparation of Health Authority meetings).
M.Sc. or Ph.D. in Biotechnology or related Life Sciences
5-8 years experience in mammalian cell culture upstream processing with viral vectors and / or viruses in an industrial environment
Advanced knowledge in primary and / or stem cell cultures in the field of Cell Therapy
Experience with CMO management and collaboration with external partners
Experience in Biosafety regulations, BL-1 and BL-2
Familiarity with GMP requirements is desirable
Experience in CHO based upstream processes for diverse Biologics formats is an advantage
Solid management skills with respect to planning / tracking, prioritization and project timelines
Sound written and oral communication skills and concise data presentation in English required