4basebio is an innovative gene synthesis company withthe ambition to provide high quality, synthetic DNA for use in genetherapy and vaccine platforms. We are expanding our teams at ourpremises just North of Cambridge, UK, to continue supporting theGMP production of our DNA products for use as a starting materialin mRNA and viral vector production as well as an API for use indrug products.We are seeking for a highly skilled and motivatedDownstream Processing Manufacturing Scientist to join our team in aGood Manufacturing Practices (GMP) environment. The ideal candidatewill have a strong background in bioprocessing, particularly indownstream operations for biopharmaceuticals including purificationand formulation process. The role will involve performingdownstream process development experiments to assure that theprocess is robust, scalable, and able to be performed in themanufacturing facility – as well as the accompanying documentation.The successful candidate will be familiar with cGMP and GDPregulations and technology transfer tasks. This position requiresgreat attention to detail, ability to work in a team environmentand a keen interest in optimisation of processes. Scientists willbe responsible for adhering to all Quality Management Systemprocedures, safety policies, and relevant parts ofcGMP.Responsibilities:Perform as a key member of the DownstreamManufacturing team, liaising with Process development and QA teamsDesign and optimize downstream processing steps, including DNApurification techniques such chromatography, tangential flowfiltration and formulationWide experience using AKTA systems, TFFsystem and deep understanding of DSP processes from a technicalpoint of viewStay up to date with current technologies andliterature as well as evaluating these new technologies/processesfor implementationProvide hands-on supporting during manufacturingcampaigns, including troubleshooting and resolving productionissuesAssist with tech transfer activities from the Processdevelopment department to the cGMP manufacturing facilityGeneratedocumentation, such as reports/experimental write-ups, that supportthe validation of processes and during the production’scampaignsExecute and deliver projects to a high standard and inaccordance with project validation plansAnalyse data fromexperiments, interpret results and implement processesRecordexperimental methods and results to a high standard and in-linewith company guidelines, maintaining QMS documentation asnecessaryAttend and participate in relevant meetings, training, anddevelopment sessionsUse, maintain and respect company equipment inaccordance with the company’s SOPs and health & safetyguidelinesTrain and mentor junior staff in downstream processingtechniques and GMP practicesUndertake any other appropriate rolesand responsibilities that reasonably fall within the role holder’sskills and experience as requestedPerson Specification:MSc inBiochemical engineering (or similar) or BSc in biological sciences,or a related discipline with relevant industry experience (2+Years)Experience of working in downstream processing in controlledenvironments employing quality standards (e.g., ISO, cGMP, cGLP,cGCP)Experience with Chromatographic process development using AKTAsystemsExperience with scale up and/or tech transfer ofchromatographic processes would be desirableExperience with TFFsystemsExperience of experimental planning, experimental validationand report writingExperience in analysis of chromatographic dataand understanding the implications of certain productimpuritiesFamiliarity with regulatory requirements forbiopharmaceutical manufacturingDoE experience using softwarepackages such as JMP would be desirable but not essentialA creativeand open mindset to tackle novel challengesExcellent team workingand communication skillsExcellent record keeping skillsMust haveright to work in the UKWhat we can offer:Competitive salary +comprehensive benefits packageIf you are interested in joining the4basebio team, please forward your CV to roleis located in Over, North of Cambridge No agencies please.Due tothe high number of applicants, if you do not hear back from uswithin six weeks, we thank you for your interest, but please assumeyou have not been selected for interview on thisoccasion.
