Lab experience for Analytical Method Development, regular and stability sample analysis. Handling of HPLC for Assay, Dissolution, Related substances tests for solid orals.
An ability to read and understand diverse literature across the many disciplines relevant to drugs, nucleic acid delivery to distill the best new ideas in the field and apply them to your work. An ability to identify the challenges associated, bottle necks in development and suggest mitigation proposals during development at various stages.
Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.