Principal Scientist Dsp Pilot
Reykjavík, Capital Region, Iceland
Within the Pilot, Innovation and Excellence (PIE) group, led the DSP team responsible for performing pilot batches (10, 50, 250, and 1000L) for innovation experiments, process development, and stability / tox material. Responsible for management of a group of scientists within the pilot group.- SME in multiple DSP technologies in PIE and support other SMEs in knowledge of larger critical systems.- Led routine and larger operations including 1000L Pilot batches. This includes proper planning and batch record oversight in coordination with QA.- Authored, completed and reviewed routine documentation such as Tech Transfer documents, study plans, batch records and batch reports.- Acted as representative of Pilot team for different products at pre-clinical stage.- Actively trained and coached other team members in Alvotech methods and procedures. - Supported both the development teams (Upstream, Downstream, Drug Product) and manufacturing (MSAT) to ease tech transfer and process development.