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QC Associate

4 months ago

London, United Kingdom Northreach Full time
We are working with a partner who seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
THE ROLE - Quality Associate
We are looking for a talented and highly motivated individual with experience of Quality Control in the cell therapy setting and GMP facilities preferably. He/she should ideally have a good understanding of the regulatory aspects of working in QC for Ph1/2 clinical manufacture including GMP requirements such as Good Documentation Practice
MAIN RESPONSIBILITIES:-
* Support Clinical Trial manufacturing through QC testing across multiple disciplines including microbiology, mammalian cell culture, flow cytometry, qPCR and potency testing.
* Assist with the qualification and validation of test methods, processes, and equipment to ensure their suitability for use in support of Clinical Trial manufacturing.
* Good Documentation Practices in the recording of data and authoring of reports.
* Support with the selection and purchase of appropriate QC laboratory equipment/materials.
* Assist with technology transfer of QC test methods from the Analytical Development Group and Participate with equipment qualification activities.
* Take part in the authoring of reports, forms, SOPs and regulatory documentation as required and support QC stability programmes.
* Assist in the stock management and upkeep of the QC Laboratories including cleaning and maintenance of instruments.
EXPERIENCE WE ARE LOOKING FOR:-
* Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process.
* Understanding and familiarity of pharmaceutical GMP regulations
* Excellent attention to detail and ability to accurately follow SOPs
* Minimum of 1 years’ experience in a GMP QC laboratory
* Skills/Specialist knowledge Experience with a range of biopharmaceutical and cell based techniques including some or all: Aseptic technique, Sterility testing, Cell Counting, Flow cytometry, PCR, Mammalian cell culture, Potency testing
* Experience supporting the qualification of assays (ICH) for the batch release and stability testing of cell-based therapies
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees