Job Reference: J5631177
Updated On: 21/03/2019
Status: Open to Applications
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Role OverviewAn incredible opportunity for a QC Lead to join a rapidly expanding Cell Therapy company based in the Hertfordshire area. As the QC Lead you will be responsible for the build-out and oversight of a new QC Laboratory for the testing of T Cell therapeutics.
Key Duties and ResponsibilitiesYour duties as the QC Lead will be varied however the key duties and responsibilities are as follows:
1. Recruit and train a team of Quality Control Associates and Scientists.
2. Design and implement assay qualification protocols for final product and in-process testing. Examples of proposed assays: flow cytometry, qPCR, endotoxin, and sterility testing.
3. Liaise with the Facility Management for coordination of manufacturing activities and warehousing of raw materials.
4. Prepare, Review and Revise SOPs and Protocols along with preparing and reviewing certificate of analysis or reports for review by Quality Assurance.
Role RequirementsTo be successful in your application to this exciting opportunity as the QC Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science discipline along with experience working within Quality Control for Biopharmaceuticals or ideally Cell Therapy.
2. Proven industry experience in establishment, qualification and validation of assays related to cell therapy product such as flow cytometry and PCR.
3. Knowledge and practical experience working within a regulated facility (GLP / GMP) in conformance with EU, FDA and/or ICH standards.
Key Words: Quality Control | QC | Cell Therapy | PCR | Flow Cytometry | Cell Culture | Analytical Development | GMP |
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