Senior Scientist - Manufacturing
- Experience Level
- Experienced (non-manager)
Hobson Prior has partnered with a clinical-stage immunotherapy organisation who are looking for a Senior Scientist to join them on a permanent basis. This role has an amazing opportunity to be part of a growing team with plenty of development opportunities.
Please note that to be considered for this role you must have the right to work in this location.
- You will deliver technical expertise for the execution and troubleshooting manufacturing process.
- To recognise need for and develop new operational systems when required to ensure robust manufacturing operation.
- Ensure and promote conformity to the Quality Management System.
- Lead appropriate risk management practices to build manufacturing process robustness
- Identify, prepare, review and revise GMP documentation including BMRs, SOPs, change control, manufacturing protocols and reports.
- You will manage and maintain a GMP manufacturing facility to meet FDA, EU and MHRA guidelines.
- Provide team leadership, supervision and line management to scientists and manufacturing technologists working within the of the manufacturing team.
- Deliver input to identify and define work packages in manufacturing projects, elements of tech transfer activities and procedure development. Oversee and support work package execution.
- Lead planning and scheduling of team activities, supported by manufacturing scientists.
- Deliver subject matter expertise and training to the manufacturing group within a specific equipment or key subject matter area.
- Liaise with internal and external Facility Management functions for coordination of manufacturing activities and warehousing of raw materials.
- Ensure reporting and completion of deviations management, route cause analysis, process risk management and CAPA.
- Previous experience with and planning of manufacturing activities.
- Leadership of EHS activities to create and promote high safety standards.
- Excellent attention to detail and ability to correctly create and follow GMP documentation.
- Previous experience with management of T cell therapy manufacturing activities and site- site tech transfer.
- A strong understanding of T cell culture and immunology.
- Previous experience in team leadership within a busy Grade C or similar cleanroom environment.
- Experience in developing processes for T cell manufacture.
- Understanding of and experience with GMP regulations, ATMP guidelines aseptic processes and cleanroom environments.
- Educated at a PHD in biological sciences, engineering or related field and at least 5 years progressive experience in a cell therapy or related field in GMP manufacturing.
- Have technical expertise in T cell manufacturing methods and equipment.
- Excellent at problem solving abilities to identify and implement solutions.
- Excellent verbal and written communication skills.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.