Upstream Process Development Associate I/II

Position Summary

KBI Biopharma seeks to fill a role for Upstream Cell Culture Process Development Associate. This person will lead and assist in cell culture and harvest projects for mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.

Position Responsibilities

• Assist 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 rate, specific productivity, and bioreactor agitation and gassing scale up/scale down.
• Perform data entry and plotting, generate presentations and support writing of technical reports using MS Office (Excel, PowerPoint and Word).
• Maintain detailed batch sheets and data binders with shake flask and bioreactor test results following good documentation practices (GDP).
• Assist in data analysis using statistical software like Design Expert (DOE), JMP, etc. and help with writing technical documents and reports.
• Maintains a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot-scale runs.
• Serves as a participant on process development teams and coaches junior individuals on cell culture techniques.
• If necessary, interacts with client to present data, provide responses to client queries and help take projects from start to finish, either independently or in teams of 2-3 individuals.
• Assist in process transfer from process development to manufacturing.
• Experience in medium development will be a plus

Position Requirements

• Bachelor’s and 1-3+ years’ experience, or master’s degree and 2+ years’ experience in Chemical Engineering, Biotechnology or related area.
• Working knowledge of mammalian cell culture.
• Advanced ability with Microsoft Office (Excel, PowerPoint and Word).
• Demonstrates ability to work both independently and as a member of a team.
• Excellent customer service skills and the ability to meet strict client deadlines.
• Flexibility of hours to support cell culture processes over weekends (2-4 weekend days per month) and holidays. Weekend and holiday hours are compensated as a premium in addition to base salary.