Key Duties and Responsibilities
Your duties as the Senior Process Workstream Lead will be varied however the key duties and responsibilities are as follows:
1. As the Senior Process Workstream Lead, you will be responsible for large strategic project design technical deliverables (either developed internally or by approved 3rd party engineering vendors), ensuring adequate engineering and scope development, along with overseeing the detailed design efforts to meet project requirements.
2. As the Senior Process Workstream Lead, you will be an experienced leader with coordination and people management experience within matrix organisations.
3. As the Senior Process Workstream Lead, you will have a strong background within Gene Therapy manufacturing and experienced single use systems including bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washers. Manufacturing experience within USP and DSP (upstream & downstream) bioprocess environments is the minimum expectation, gene therapy experience is preferred.
4. As the Senior Process Workstream Lead, you will be an expert in single use systems and automation used within the pharmaceutical industry. You should have strong knowledge of cGMP and ICH guidelines. Knowledge of FDA CMC, ISPE and PDA Guidance is preferred.
