Upstream Technology Transfer Lead
6 month contract initially
Up to £100 per hour
Cpl Life Sciences are recruiting for an experienced Upstream Technology Transfer Lead to join a global pharmaceutical company based in Cambridge, remote working can be considered.
This is a senior position is playing a critical part to supporting with the Covid vaccine.
• Transfer and support assigned project(s) to CMO(s) as upstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support and deviation write ups, process validation documentation review/approval, campaign summary report authoring, and routine presentations to cross-functional teams and management
• Builds and maintains relationships with partner groups
• Proactively addresses risks/issues and influence partners/CMOs to avoid non-conformances and enable efficient transfers
• Represent function on cross-functional teams
• Participate in design or analysis of lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
• Write technical assessments and/or reports and deliver presentations
• Hands on cell culture experience with stirred tank bioreactors (Stainless or single use)
• Cell culture tech transfer and/or development experience
• Hands on or tech transfer experience to at least 200L scale or above
• Fundamental understanding of upstream unit operations such as mixing, bioreactor, and filtration.
• Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
• Knowledge of GMP manufacturing principles and documentation
• Skilled in root cause analysis and problem-solving
Please apply within or for more information please contact firstname.lastname@example.org