Job Reference: J5631308
Updated On: 11/04/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a Senior Technical Specialist to join a leading biopharmaceutical company based in the Merseyside area. As the Senior Technical Specialist in Analytical Sciences, you will be a part of the Stability Team and will be responsible for cGMP stability studies for a variety of biological products and their design, management and execution.
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 be responsible for designing stability studies, writing and reviewing protocols, evaluating data and performing trend analysis.
2. As the Senior Technical Specialist, you will liaise with other departments such as Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Teams and External Vendors to initiate stability studies and ensure they are executed and reported to the correct timings, budget and quality.
3. It will be your job to participate in internal and external quality stability audits.
4. You will provide technical expertise in Stability Studies to assist in trouble shooting any issues that occur in transfer or routine analysis.
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 scientific field (e.g. Pharmaceutical Science, Biopharmaceutical Science, Biotechnology, Biochemistry, etc.) is required for your application.
2. Proven industry experience in working with and managing stability studies is essential.
3. A working knowledge and practical experience working with biological products within development will be beneficial.
Key Words: Biopharmaceutical | Pharmaceutical | Biologics | Stability | Analytical | Technical Specialist | cGMP | Study Design | Study Management | Science
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