Scientific Officer – GMP Biologics Manufacturing
Our client, a world-renowned oncology therapeutics organisation, is seeking a scientist to work within an innovative biomanufacturing unit to deliver novel biologic oncology drugs for early phase clinical trials.
They are looking for a driven and self-motivated individual to...
· Assist on the development, scale-up and GMP manufacture of biologics investigational medicinal products
· Support 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
· Support the maintenance, operation and validation of the production facility and equipment
· Generate high quality technical documentation, as well as required GMP documentation and support regulatory filing
· Assist other members of staff and support production 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 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 sponsored by the organisation.
· Degree or equivalent in a life science discipline
· Biologics cell culture and/or purification processes
· Experience with cell culture technology and operation of bioreactors
· Experience with scale up of biologics manufacturing processes
· Excellent documentation and planning skills
· Working in a quality management system under GMP
· Good understanding of protein / antibody analytical and characterisation methods
· Experience with FMEA tools for performing process risk assessments
· The ability to work closely with teams across the various functions in process development, manufacturing and quality control to find solutions in sometimes challenging situations.
Location: Greater London
Salary: Up to £32,000 + Benefits
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