Job Reference: J5631472
Updated On: 16/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Technical Specialist to join a leading gene therapy company based in the Merseyside area. As the Senior Technical Specialist, you will be responsible for the supervision of testing and GMP release of biologic products within the analytical department, you will be involved in method optimisation, validation and transfer and will also lead laboratory operations and procurement activities.
Key Duties and ResponsibilitiesYour duties as the Senior Technical Specialist will be varied however the key duties and responsibilities are as follows:
1. You will plan and review experimental data and develop procedures for the routine development and testing for the GMP Release and Stability processes. It will be your responsibility to ensure this is carried out on budget and in compliance with the quality standards in place.
2. As the Senior Technical Specialist, it will be your responsibility to write and review qualification, validation and transfer protocols and reports for assays in the analytical sciences department.
3. You will be involved in troubleshooting and resolving issues with the assays during technical transfer or routine production.
4. Your role will include writing proposals and supplying appropriate costs for approval in order to support the management of the departments expenditure.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Technical Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science subject (e.g. Biology, Biochemistry, Pharmaceutical Science, Immunology, Molecular Biology, etc.)
2. Proven industry experience in a pharmaceutical or biopharmaceutical environment is essential for your application, especially within a GMP setting.
3. A working knowledge and practical experience with biomolecule analysis, quality control, writing technical specifications and test methods, performing equipment qualification and test method validation, as well as working in an analytical testing environment.
Key Words: Pharmaceutical | Biopharmaceutical | QC | Quality Control | Stability | Release | Troubleshoot | GMP | Analytical | Biologics | Assay Development | Chromatography | Plate-based Assays | Gene Therapy
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