GMP QC Scientist

at  eXmoor Pharma Concepts Ltd

Job title: QC Scientist
Reporting to: Senior QC Scientist
Department: GMP
No of Direct reports: 0
Location: Bristol

SUMMARY:

eXmoor helps clients with their manufacturing of cell and gene therapies (CGT) and biopharmaceuticals. We provide; (1) translation consultancy to close the gap between R&D and clinical manufacture, (2) process development services from our wet labs in Bristol, (3) capital project design through to licensing and (4) GMP manufacturing for early phase clinical trials.
The QC Scientist will perform assays related to drug product manufacturing, critical raw materials testing and, if required, assays in support of process development. This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your quality management career.
Job Description:The GMP manufacturing facility will be capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility will comprise of two technical areas (Process/Analytical Development & GMP clinical phase production, including a small fill/finish capability) and all associated QC, both working closely together such that processes developed in the PD/AD area will be transferred at scale to the GMP suites & GMP QC Analytical laboratories.
The QC Scientist will be responsible for the conduct of analytical assays in support of manufacturing and product release whilst also supporting the PD function when required, in performing assays and reporting data to support the development of new processes. The QC scientist should display a pride in maintaining the laboratory function and the quality of their work.

​DESIRABLE QUALIFICATIONS & EXPERIENCE:

• Understanding of GMP and operating within a QC analytical function
• Development of analytical methods
• Writing of analytical procedures
• Presenting and reporting data to senior members of the eXmoor team
• Operating within a QMS and experience in reporting deviations and OOSs.

As a QC Scientist you will have the following main areas of responsibilities and duties:
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