HRS are currently looking for a Biochemistry Assay Development Lead to join a leading Biopharmaceutical company based in the West Sussex area. As the Biochemistry Assay Development Lead you will be responsible for developing and validating assays including HPLC, ELISA, Western Blots, SDS Page and more.
In this role, you will act as the Technical Lead and train junior members of the team as well as lead technical projects from Early R&D up to QC. This role will require presence in the lab.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Biochemistry Assay Development Lead will be varied however the key duties and responsibilities are as follows:
1. In this role you will develop assays and validating them, following ICH, FDA guidances. Assays include HPLC, ELISA, Western Blots, SDS Pager and more.
2. In this role, you will act as the technical expert and you will be highly competent in troubleshooting. You will support junior members of the team and train them.
3. You will drive projects to completion and ensure you work closely with the Team Leaders.
4. Part of your role will be reviewing and updating sections of regulatory documentation such as CMC Module 3.
To be successful in your application to this exciting opportunity as the Biochemistry Assay Development Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biochemistry, Chemistry, Biological Sciences and more. A PhD is advantageous.
2. Proven industry experience ideally in a biopharmaceutical environment, where you will be focused on biochemical assay development and validation.
3. Able to adapt to changes and communicate clearly with peers and colleagues.
Key Words: Assay Development / Assay Validation / HPLC / UPLC / SDS PAGE / Biologics / Large Molecules / Western Blot / ELISA / Immunoassay / Proteins / Antibodies / CMC / ICH / FDA / CMC / R&D / West Sussex