||Is responsible for achieving project goals for one or more projects of moderate complexity within the development and registration phase.
* Act as a generalist with Interdisciplinary competence and experience.
* Function as study director, principle investigator or Sponsor representative (in case of outsourcing) on studies required for registration of biological products. These studies include but are not limited to GLP, GCP, seed lot, establishment of specifications, and stability.
* Lead a team to prioritize project work based on analysis of strategic importance, tasks outstanding, obstacles or barriers and deadlines. Ensures information flow between the individual disciplines.
* Responsible for developing a project plan that works to achieve progression criteria using sound technical and scientific processes in the shortest amount of time with the least cost.
* Is open for general tasks within the organization and between CRO related to GLP, GCP and/or study coordination.
* Plan and execute development studies, write registration dossier, manage questions from authority and complete the registration for an approval of biologicals.
* Work with and train young or less experienced scientists on development and registration of biologicals.