Senior Scientist Bioanalytics

Job Description

Senior Scientist BioanalyticsLocation: Potters BarPlease note there is no closing date for this role. We recommend candidates to apply early to avoid disappointment.12 months fixed-term contract with strong potential to become permanent.Please note that this is a lab-based position. To avoid unnecessary contact, first stage interviews will be held virtually but there will be a requirement to visit the facility at the final stage.About the BDU:The Biotherapeutics Development Unit (BDU) is a specialised Biologics Process Development and Manufacturing Department located at Clare Hall (Potters Bar), in South Mimms. The site is within the UK "golden triangle" for biotech within easy commute of London, Cambridge, Stevenage and the surrounding Hertfordshire area.The BDU Manufactures the whole spectrum of biotherapeutics including: cell therapies, monoclonal antibodies, recombinant proteins, DNA and viral vectors.The BDU is looking to restructure and is entering a new and exciting phase. Similar in activities to a start-up, this role will help position the BDU to be the foremost UK biotherapeutics manufacturer in the oncology space through technical excellence.The BDU is a small team of less than 20 staff, so operates as a highly agile and entrepreneurial service-provider. Staff in the unit are being cross-trained to facilitate operations and coverage across all areas of Process Development and Manufacturing (Upstream, Downstream and Analytics). Thus, the BDU is a truly cross-disciplined and cross-trained Manufacturing Science and Technology (MS&T) team.The role:The role is within the Biotherapeutics Development Unit (BDU) to lead on the process development, scale-up and GMP manufacture of novel biologics investigational medicinal products for early phase clinical trials sponsored by Cancer Research UKs Centre for Drug Development. To provide technical and scientific expertise on a broad range of biologics product types and design robust manufacturing processes. To work in a matrix-managed environment, utilising cross-functional skills in cell culture / fermentation technology and/or protein / antibody purification and bioanalysis. The role is best suited for a highly experienced QC Bioanalyst or Senior expert with an industry background and especially GMP experience. However, suitably qualified candidates with postdoctoral (academic) or R&D experience will be equally considered.This role is responsible for oversight and performance of routine testing on investigational medicinal products including final product, bulk drug substance, in-process, raw materials and packaging materials. The Senior Scientist Bioanalytics will lead the development of novel assays for new projects and help to maintain compliance in our Good Manufacturing Practice (GMP) facility - the BDU.Who were looking for:Were looking for a candidate who has the charisma to be a player on the UK Biotech landscape. The role is best suited for an ambitious and highly experienced analytics expert with an industry background and especially GMP experience. However, suitably qualified candidates with postdoctoral (academic) or R&D experience will be equally considered.Suitability for the role will primarily be upon the demonstration of skills and knowledge for bioanalytical technology: An understanding of assay development across platforms, Quality Control through analytical sciences, tech transfer, instrument validation, facility environmental quality control and ongoing GMP control testing, IMP testing and stability studies. However, a strong driver is to find a self-driven candidate who is ready to overcome challenges, drive excellence and create value for the Charity. This role is ear-marked for ongoing development into a QC Manager role with Regulatory oversight.You can find out more about this role by reviewing the candidate pack at our website via the button below.