Small Molecule CMC Leader - Senior Director

Senior Director, Chemistry Manufacturing and Controls (CMC) Project Leadership

Position Summary

You will lead CMC (Chemistry, Manufacturing and Controls) for a Medicines Development and Innovation programme. You will lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule, biopharm or CGT) from Commit to Phase 2 (C2P2), through the development of the Phase 3 (P3)/commercial process, the file, review and launch and the completion of the major clinical & CMC/SC lifecycle work. The role holder: i) engages with the medicine 6 to 12mths prior to C2P2; ii) takes accountability from the early CMC Leader at C2P2; iii) leads delivery of the P3/commercial process, clinical supplies and files; iv) ensures the successful execution of the process performance qualification (PPQ), establishing continuous process verification (CPV) and pre-approval inspection readiness; v) ensures the global file, review...