Job description
Site Name: UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence
Posted Date: Feb 11 2025
As the Senior Director, Chemistry Manufacturing and Controls you role will be to 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, and launch readiness; vi) delivers the further lifecycle P3 studies and CMC/SC sub-projects; and then vii) transitions to the MSCL and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan.
The Sr. Director role leads projects with CMC budgets in the >£30M range and/or peak year sales in excess of £500M. The role is complemented with a director role which leads projects with CMC budgets in the or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.
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