Walker Cole International is seeking a Senior Scientist (Analytical CMC) to join a leading biotherapeutics company. This full-time position is based in Oxfordshire, and offers a unique opportunity to lead the development and validation of cutting-edge analytical techniques for immunotherapy products within a dynamic and innovative environment.
Key Responsibilities as the Senior Scientist (Analytical CMC):
- Lead the establishment, qualification, and validation of analytical assays to support CMC activities for biotherapeutic products.
- Develop and perform characterisation assays, ensuring scientific accuracy and adherence to regulatory standards.
- Provide technical leadership for assay transfers to Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).
- Author and review standard operating procedures, assay reports, and analytical methods in line with good quality guidelines.
- Manage and mentor junior colleagues, providing training and guidance.
To be successful in your application for the Senior Scientist (Analytical CMC) position, you will have the following expertise:
- Ph.D. or equivalent experience in a life science discipline.
- Proficiency in the development and validation of techniques such as ELISA, dPCR, qPCR, Western blotting, HPLC, and cell-based potency assays.
- Practical knowledge of ICH Q2, assay troubleshooting, and tech transfer.
- Experience with Design of Experiments (DoE) and relevant software.
Regulatory Affairs | Senior Scientist | Analytical CMC | Immunotherapy | Biotherapeutics | Oxford | ELISA | qPCR | GMP | ICH Guidelines