We are currently looking for a Scientist (Analytical Sciences) to join a leading CRO company based in the Liverpool area. As the Scientist (Analytical Sciences) you will be responsible for performing analytics in order to facilitate the transfer and phase appropriate validation of analytical methodologies for non-GMP and cGMP testing of biological products.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Scientist (Analytical Sciences) will be varied however the key duties and responsibilities are as follows:
1. You will write procedures for analytical methods, equipment, processes to the required quality for cGMP compliance and support the optimization, phase appropriate validation and/or technical transfer of developed methods for cGMP testing.
2. The Analytical Scientist will perform testing of utilities, raw materials, process development, in process, product release and stability to ensure delivery on time, on budget and in compliance with the established quality standards. They will also lead the management of samples for projects assigned to them whilst executing method qualification/validation protocols and assist in writing the associated reports as required.
3. You will be responsible for performing trend analysis of analytical results and ensuring test specifications are met and reporting out of specifications to Snr Manager. Another responsibility will be to generate stability data (including Forced Degradation) through performing analytical testing, stability data collation/trending and writing stability protocols/reports.
4. A key duty for this role will be to support the installation and validation of analytical equipment by writing and executing equipment validation documentation including but not limited to URS, trace matrix, IOQ, SOP's, protocols and reports in line with quality procedures and guidelines.
To be successful in your application to this exciting opportunity as the Scientist (Analytical Sciences) we are looking to identify the following on your profile and past history:
1. Relevant degree in the life sciences/pharmaceuticals sector along with biopharmaceutical/pharmaceutical experience is essential for this role.
2. Proven industry experience in analysis of biomolecules, writing procedures, protocols and reports. Knowledge of pharmaceutical standards and regulations within an GMP environment is key for this role.
3. It will also be crucial to have working knowledge of analytical techniques including but not limited to Electrophoresis (SDS-PAGE, Western Blot, IEF), Chromatography (SE-UPLC, RP-HPLC, AEX, HILIC), Immunoassays (ELISA, Potency, HCP)
Key Words: Analytical | Scientist | HPLC | Chromatography | Immunoassay | ELISA | Western Blot | Pharmaceutical | CRO | Validation