QC Lead Immunology (Biologics)
Exciting new opportunity with a research-led, global pharmaceutical company!
My client, who focusses on the discovery and development of novel biological entities (mAbs) and biosimilars, is based in Switzerland and is looking for a QC Lead Immunology specialising in Biologics.
You will be the point of client contact for Quality/Analytical aspects of a project from beginning to end with accountability for assigned project deliverables.
Key responsibilities for the individual with involve:
- Developing and leading external or internal technology transfer projects into the Quality Control department.
- Responsible for the execution of analytical immunology test method transfer, optimization and validation to meet project requirements.
- Provide regular updates to CMC program lead, project management and Head of Quality Control on immunological methods.
- Participate in project team meetings as assigned.
- Assist CMC Program Lead, project management and Head of Quality Unit to ensure that resources assigned to the project shall deliver according to expectations and client satisfaction.
- Manage project strategy, objectives, specifications, deliverables, timelines and tasks with respect to immunological analytics.
- Write and review test method transfer and validation protocols and reports (including development reports and similarity/comparability assessments) as required.
- Manage regulatory feedback implementation plan with respect to immunological assays.
- Support immunological analytical strategy (including specification setting and characterization assessment) adapted to development phase as per regulatory interactions/guideline interpretations.
Proven experience in functional and binding ELISA is highly desirable and relevant biologics experience in an industrial setting under GMP is required. Ideally you will have worked with CMOs.
Having QC experience and knowledge of current analytical techniques is a requirement as is excellent communication skills.
If you would like more information about this great opportunity to work with a leading biopharma, please get in touch with Nisha Patel on 0203 861 8210 or via email on email@example.com.