Senior Scientist - Analytical CMC

We have an exciting opportunity for a Senior Scientist - Analytical CMC to join a leading biotechnology company based in the Oxfordshire area. As the Senior Scientist - Analytical CMC, you will be responsible for leading the development of multiple analytical techniques across a broad range of assays that are essential for the testing of immunotherapy products.

Your duties as the Senior Scientist - Analytical CMC will be varied however the key duties and responsibilities are as follows:

1. Take a lead role in the establishment, qualification, and validation of analytical assays to support Chemistry, Manufacturing, and Control (CMC) activities.

2. Provide technical leadership on assay transfers to Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).

3. Author and review standard operating procedures, assay qualification/development/transfer/validation reports, and analytical methods, ensuring adherence to good quality guidelines.

4. Line manage junior colleagues and provide necessary training while contributing to the routine running of the laboratory and maintenance of equipment.

To be successful in your application to this exciting opportunity as the Senior Scientist - Analytical CMC we are looking to identify the following on your profile and past history:

1. PhD or equivalent degree in a life science discipline (e.g. Biochemistry)

2. Proven industry experience working in a laboratory within a Biotechnology/Pharmaceutical setting using techniques such as ELISA, PCR, HPLC and Western Blotting.

3. A working knowledge and practical experience with assay development, qualification/validation, and technology transfer


Key Words: Senior Scientist / Analytical CMC / Biotechnology / Immunotherapy / Assay Development / Validation / Technology Transfer / GMP / Oxfordshire / Biotherapeutics / ELISA / PCR / HPLC / Western Blotting / Management