We are currently looking for a Scientist (Method Development) to join a leading CRO company based in the Liverpool area. As the Scientist (Method Development) you will deliver and support a wide range of activities associated with the design, development, optimization, phase appropriate validation, transfer, and application of analytical methodologies to enable in-process development testing, non-GMP and cGMP release testing of biological products.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Scientist (Method Development) will be varied however the key duties and responsibilities are as follows:
1. The Scientist will support Project leads on delivery of internal and Client-based work packages through the planning, design, delivery and reporting of activities within the analytical laboratories to meet project timelines in line with policies and procedures. They will ensure maintenance of stock reagents and consumables and laboratory housekeeping for all work performed.
2. You will also be responsible for setting exemplary standards within the laboratory and facility in compliance with Development, Quality and EHS Policies and Procedures.
3. It will also be crucial to drive 5S and operational excellence initiatives as a means for continuous improvement to ensure that department is a high performing team as well as lead on the delivery of new capital equipment items and train others in procedures, techniques, equipment, and technologies to increase Biologics Development analytical capabilities.
4. Another responsibility will be to complete all laboratory or batch related documentation in a timely and compliant manner, participating in reviews of the documentation to obtain quality sign off when necessary. You will also be a subject matter expert in areas relating to analytical development, including but not limited to core technologies, characterization and cell and analytical molecular biology and additionally GMP analysis.
To be successful in your application to this exciting opportunity as the Scientist (Method Development) we are looking to identify the following on your profile and past history:
1. Relevant degree (BSc/MSc) in the life sciences/pharmaceuticals sector along with biopharmaceutical/pharmaceutical experience is essential for this role. Having a PhD (or equivalent industrial experience) in a relevant life sciences field would be ideal.
2. Proven industry experience within the biopharmaceutical or pharmaceutical industry (gene therapy most ideal) and experience working in analytical development, performing method development, equipment qualification, phase appropriate validation and testing.
3. It will also be crucial to have working knowledge of areas within analytical sciences including but not limited to Electrophoresis (SDS-PAGE, Western Blot, cIEF, CE-SDS), Chromatography (SE-UPLC, RP-HPLC, AEX, HILIC), Immunoassays (ELISA, Potency, HCP), Molecular Biology (qPCR, ddPCR, sequencing, residual DNA) or Characterisation (LC-MS, AUC, DLS, DSC, TEM).
Key Words: Analytical | Scientist | Method Development | Method Validation | HPLC | Cell and Gene Therapy | Process Development | Optimisation | GMP |