Process Development Scientist I/II - Upstream #227

We seek to fill a role for an Upstream/Cell Culture Process Development Scientist. This person will lead and assist in cell culture and harvest of mammalian cell lines in support of process development, scale-up, and technology transfer to cGMP manufacturing. Position Responsibilities:Supports product development efforts in the process and manufacturing areasConceptualizes and proposes process development and manufacturing based on biopharmaceutical dataProvide technical support for clinical manufacturing and product testingWorks toward developing a broad knowledge of state-of-the-art scientific principles, theory of cGMP and other regulatory requirementsAct as spokesperson on development programs and interact positively and productively with clientsLead and support the team in the set-up, operation, and associated analysis of cell culture and bioreactor processes including bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis for shake flask and various scale bioreactors (ambr15, ambr250, 3 L & 15 L glass bioreactors, 50 L and 200 L Xcellerex single-use bioreactors)Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors. Required to perform calculations for growth date, specific productivity, bioreactor agitation and gassing scale-upMaintains a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot- scale runsResponsible for producing high quality documentation and client reports suitable for publication and regulatory requirementsAdheres to all safety requirements and assures that departmental employees comply with required safety proceduresPosition Requirements:Degree within Chemical Engineering, Biotechnology or related area:Bachelor''s degree with 5+ years'' experienceMaster''s degree with 3+ years'' experiencePh.D. with 0-2 years'' experienceWorking knowledge of mammalian cell culture

Created: 2021-11-29