Reporting into the Senior Director, DS development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable and robust processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs).
Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and CMC sections of regulatory dossiers, and participation in department or functional initiatives.
The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control.
The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently.