Mantell Associates are exclusively partnered with the most innovative CDMO in the industry, who specialise in the Cell and Gene therapy, Drug Delivery and Viral Vector space!
This role will suit someone with substantial prior experience in QC within a CGT unit or related pharmaceutical industry environment and looking to step up into a leadership career.
Performs Quality Control (QC) biological/cell based testing of Cell Therapy in-process, release and stability samples. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, cell counts (manual and automated), and immunoflourescence microscopy/spectroscopy assays.
Write original and revise current SOPs, Forms and Test Records. Writes edits and approves Deviations and CAPAs as required. Responsible for initiating Change Controls and completing necessary documentation
Actively participates in support of Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols
BA or BS degree in related field.
Team leader and excellent communicator, quality-minded and customer-oriented.
Experience in QC equipment qualification.
Demonstrated knowledge in biological, cell based assays including flow cytometry.
Should possesses knowledge of how to execute methods/procedures and operate equipment.
Should perform tasks with strict adherence to cGMP and cGDP principles.
Mantell Associates a specialist Pharmaceutical and Life Sciences headhunting organisation. For more information on this role, please contact Carl Gbolade on+44 (0)2038547728 or firstname.lastname@example.org.