Upstream Process Development Associate I/II

KBI Biopharma seeks an Upstream Cell Culture Process Development Associate to 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.

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. 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.
• Maintain a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot-scale runs.
• Serve as a participant on process development teams and coach junior individuals on cell culture techniques.
• Interact with clients 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.

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).
• 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.

Benefits

• Annual bonus structure for all employees.
• Medical, dental, and vision coverage.
• Paid PTO and holidays.
• Sabbatical program.
• 401K matching with 100% vesting in 60 days.
• Employee recognition programs.

Pay

$50,000–$70,000 per year. Salary and job title will be based on the selected candidate’s qualifications and experience.