Biotherapeutics Production Manager - Hertfordshire
Jason at CK Science is currently recruiting for a Biotherapeutics Production Manager to join the pioneer of prevention, diagnosis and treatment of cancer with over a century of research experience and consistent progress in the fight against cancer. This role is offered on a full time permanent basis at an innovative, purpose built biomanufacturing unit to deliver novel biologics oncology drugs for early phase clinical trials in Cambridge. It comes with a competitive salary and strong benefits package.
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 for Drug Development. You will gain insight into clinical drug development at the forefront of science in return for your expertise and skill to develop high quality drug product candidates.
We are looking for a driven and self-motivated individual to:
- Lead 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
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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)
- 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)
If successful you will be joining an organisation with a passion, determination and ambition to set themselves more and more challenging targets, which means you'll be constantly striving to accelerate delivery of novel biologics therapies to early phase clinical trials. If you love drug development, particularly in oncology this Biotherapeutics Development Unit is a great place to be.
For more information or to apply for this Biotherapeutics Production Manager position please contact Jason on +44 (0)1438 842963 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST40072 in all correspondence.