Job Description
Reporting to the Director CMC Technical Operations, the company wishes to appoint a CMC Associate Director who will provide technical support and oversee development, technological transfer, manufacturing and supply activities with CDMOs, enabling for preclinical and clinical development of PET radiopharmaceuticals. This position requires broad-based expertise to help create and implement phase-appropriate solutions.
Responsibilities:
1. Responsible for the development and management of outsourced PET radiopharmaceutical CMC project activities at various stages of drug development. Delivering milestones within agreed time, resources, and cost.
2. Oversee preparation of CMC documents for IND/IMPD or NDA/MAA submissions.
3. Preparing and reviewing relevant CMC-documents such as reports and SOPs.
4. Provision of technical expertise and support and adequate scientific interpretation and guidance.
5. Management of third party CDMOs activities, partner network and innovation, ensuring the accuracy and reliability of the data generated.
6. Play a key role in defining and driving the radiopharmaceutical CMC strategy in terms of partners, capabilities, and innovation for the projects.
7. Develop appropriate CMC project plans and integrate these with the overall project plan. Monitor ...