EXPERT BIOTECHNOLOGIST (USP)

Mantell Associates is partnered with a full integrated speciality biopharmaceutical company, who are seeking an Expert Biotechnologist focused on Upstream Manufacturing (Drug Substance Manufacturing).Expert Biotechnologist - Responsibilities:Proactively ensure the USP suite and equipment is always maintained in a state of inspection readinessPerform cGMP activities in Grade CNC, D and C areasPrepare media and buffers to set specifications in accordance with written protocolsBe a SME author/reviewer and/or approver for written procedures, SOPs, MBRs and other cGMP documentations in span of expertiseAssist in execution of technical and validation protocolsBe an SME author and reviewer of deviations relating to USP processes and help to identify root cause and appropriate CAPAsContribute towards Technology Transfer of processes to manufacturing scaleSupervise and ensure laboratory work is carried out according to cGMPHelp to provide guidance and support for less experienced members of staff to achieve a multi-skilled and engaged USP teamContribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agenciesAim to continually identify process improvement and waste elimination opportunities to help create and maintain a lean, flexible, and agile manufacturing facilityDeputise for Team Lead as requiredExpert Biotechnologist - Requirements:Education: Degree in related discipline or sufficient relevant experienceKnowledge/experience of mammalian cell culture for production of monoclonal antibodies and recombinant protein therapeutic productsHands-on experience in operating upstream processing equipmentKnowledge/experience of cell culture principles, techniques, scale up, technology transfer and process validation activitiesA minimum of 5 years in biopharmaceuticals or technical field, desiredProven experience of collaborative team-working and leading when appropriateBe able to work in accordance with cGMP and EHS practices, conducting all activities in a compliant and safe mannerWilling to take on additional activities with little or no supervisionMantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.