Upstream Process Development Associate I/II

KBI Biopharma•Durham, NC

About The Position

KBI Biopharma seeks an Upstream Cell Culture Process Development Associate to lead and assist cell culture and harvest projects for mammalian cell lines, primarily CHO variants. The work supports process development, scale-up, and technology transfer to cGMP manufacturing. The role includes maintaining and monitoring experiments in shake flasks and bioreactors, performing process calculations and data analysis, documenting results, and contributing to technical reports and presentations. The associate participates in process development teams, helps coach junior colleagues, and may interact with clients to present data and respond to questions. The role also supports transfer of processes from development to manufacturing. Medium development experience is a plus. Flexibility is required to support cell culture processes on weekends and holidays; weekend and holiday hours are compensated at a premium in addition to base salary.

Requirements

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

Nice To Haves

Experience in medium development.

Responsibilities

Assist with setup, operation, and analysis of cell culture and bioreactor processes, including bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis.
Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors.
Calculate growth rates, specific productivity, and bioreactor agitation and gassing scale-up or scale-down.
Enter and plot data, prepare presentations, and support technical report writing using Microsoft Office.
Maintain detailed batch sheets and data binders in accordance with good documentation practices (GDP).
Assist with data analysis using statistical software such as Design Expert (DOE) and JMP, and help prepare technical documents and reports.
Maintain a cell culture-specific project plan, including raw material and equipment availability, in preparation for laboratory and pilot-scale runs.
Participate on process development teams and coach junior individuals on cell culture techniques.
When needed, present data to clients, respond to client queries, and help manage projects independently or in teams of two to three.
Assist with process transfer from process development to manufacturing.