Would you like the chance to join an award winning global biotechnology Company who focus on development and commercialisation of innovative gene therapies to change lives. My client has a broad pipeline with one clinical trial ongoing and two more coming in 2019/20 which allows more opportunities to change lives by providing directed gene therapy as a life-long and potentially curative treatment.
This opportunity will allow you to be involved in establishing a GMP compliant QC lab to support the in process testing of AAV products manufactured at the GMP facility. Furthermore, our client will provide a pro-active environment where you will be a part of an effective team working within QC and across company departments where required.
Tasks:
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Play a vital role in the manufacturing team with environmental monitoring ensuring the clean rooms maintain compliance. Clean room environment is grade D and C.
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Ensure you are following protocols and SOPs to guarantee effective performance of analytical methods generating valid and reliable data.
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Contributing in analytical and OOS investigations. This will allow a culture of continuous improvement, by you having a keen eye of detail to seek out unusual observations, unexpected findings which will need to be reported to QC manager.
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Moreover, you will be a part of a QC team in establishing a GMP compliant QC lab to support the in process testing of AAV products.
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This role will involve analytical testing programmes according to GXP, with defined schedules and responsibilities.
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Participate in stability testing and trending of buffers used throughout the production procedure.
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Working within a QMS to include change control systems, deviations and OOS reporting.
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Furthermore, provide essential input for reporting of data, generation of certificates, protocols, SOPs and internal written reports.
If you are a Self-motivated individual with the ability to work in a diverse team who are achieving a high standard of work, please do reach out and gain your next career step up!
or 01737 761 697