Production Manager – GMP Oncology Biotherapeutics
Are you a self-motivated and sharp minded individual with a passion to work within an innovative biomanufacturing unit to deliver novel biologics oncology drugs for early phase clinical trials? Are you an experienced scientist looking for an opportunity to expand your knowledge and develop skills in the rapidly advancing field of new cancer therapies?
Our Biotherapeutics Development Client has a vacancy for an experienced Production Manager within its purpose built manufacturing facility. The unit is licensed by the MHRA to develop and manufacture biological anticancer agents for use in early phase clinical trials and is a state of the art facility.
The position offers an exciting opportunity to work as part of a multi-functional team to develop and supply novel oncology drug products to clinical trials. They are looking for a driven and self-motivated individual to...
• Lead on the production manufacture of biologics investigational medicinal products
• Lead the validation and performance of aseptic fill/finish processes
• Provide technical expertise in finding biomanufacturing solutions for a broad range of product types from monoclonal antibodies, recombinant proteins, viral vectors and plasmid DNA
• Lead on the maintenance, operation and validation of production facility and equipment
• Generate high quality technical documentation, as well as required GMP documentation and support regulatory filing
• Train and coach other members of staff and support senior operations manager in operational planning and scheduling of manufacturing campaigns
• Work within a quality management system to ensure timely investigations and closures of deviation, faults and audit findings and ensure regular review of CAPAs
The successful candidate will have:
• Extensive knowledge and experience of protein/antibody/DNA/virus purification techniques (including cell separation, filtration and column chromatography methods)
• Extensive knowledge and experience of mammalian and bacterial cell fermentation (experience with disposable systems desired)
• Team working spirit and ability to lead teams through development and manufacturing campaigns
• Experience with scale up of biologics manufacturing processes
• Excellent documentation and planning skills
• Good understanding of protein/antibody analytical and characterisation methods (desirable)
• Experience with FMEA tools for performing process risk assessments (desirable)
Location: Greater London
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