You will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables. Participate...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Execute Early Access Program planning: Manage all aspects of EAPs, applying risk management principles; Coordinate with cross-functional teams: Align on strategic priorities...
In this role, you’ll be responsible for overseeing the scale-up of fermentation processes from lab to commercial scale, and you will be instrumental in leading our plant start-up...
QA responsible for quality decisions in relation to batch manufacturing of Biological Intermediates (BI), Chemical Intermediates (CI) and Drug Substances (DS), in collaboration...