Bioassay / Potency Assay Senior Scientist (Analytical Development / CMC)

We are currently looking for a Potency Bioassay Analytical Senior Scientist to join a growing Biotechnology company based in the Oxfordshire area. As the Potency Bioassay Analytical Senior Scientist you will be responsible for performing multiple analytical techniques with an emphasise on cell-based potency assays.

This is a fantastic opportunity for a skilled scientist with experience in developing cell-based assays to be a part of a rapidly growing CMC team, gain expert development, and have exposure to early, and late clinical stage developments!

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

1. You will develop, qualify, and perform various analytical assays for testing of different in-process samples, drug product, and drug substance supporting CMC activities.

2. You will assist in the Tech Transfer process, write technical reports and participate in scientific meeting to present data and conclusions where required using your expert knowledge.

3. You will have the opportunity to be cross-trained over all analytical techniques, work and liaise with the R&D, USP and DSP teams as well as train and develop junior members of the team/

4. You will ensure the efficient documentation of all analytical development work to support regulatory submissions, and review activities are conducted in accordance within the companys quality systems and policies.

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

1. Relevant degree in Biological sciences or a similarly related qualification. A PhD is desirable.

2. Proven industry experience in a Biotech/Pharma setting where youve developed cell-based assays.

3. A working knowledge and practical experience with cell-based potency assays, molecular techniques, mammalian cell culture and understanding principals of Designs of Experiments ad relevant software.


Key Words: Biotech | Analytical | Analytical Development | CMC | Potency Assay | Bioassay | Assay Development | Technology Transfer | T Cell | Immunotherapy | Immunotherapies | Oxfordshire | PhD | MSc | Pharma