Upstream Process Development Associate I/II
About The Position
KBI Biopharma seeks an Upstream Cell Culture Process Development Associate to lead and assist cell culture and harvest projects involving mammalian cell lines, mainly CHO variants, in support of process development, scale-up, and technology transfer to cGMP manufacturing. The role includes setting up, operating, and analyzing cell culture and bioreactor processes at shake-flask and multiple bioreactor scales. The associate maintains experiments and project plans, documents results, supports data analysis and technical reporting, and contributes to process development teams and transfers to manufacturing. The position may involve client interactions and coaching junior colleagues. Experience in medium development is a plus.
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 and holidays, including 2–4 weekend days per month.
Nice To Haves
- Experience in medium development.
Responsibilities
- Assist with set-up, operation, and analysis of cell culture and bioreactor processes, including preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis.
- Work with shake flasks and bioreactors including ambr15, ambr250, 3 L and 15 L glass bioreactors, and 50 L and 200 L Xcellerex single-use bioreactors.
- Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors.
- Calculate growth rate, specific productivity, and bioreactor agitation and gassing scale-up or scale-down.
- Enter and plot data, generate presentations, and support technical report writing using Microsoft Office.
- Maintain detailed batch sheets and data binders with test results in accordance with good documentation practices.
- Assist with data analysis using statistical software such as Design Expert (DOE) and JMP, and help write technical documents and reports.
- Maintain a cell culture-specific project plan, including raw materials 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 necessary, interact with clients to present data, respond to queries, and help take projects from start to finish independently or in small teams.
- Assist with process transfer from process development to manufacturing.
Benefits
- Weekend and holiday hours are compensated as a premium in addition to base salary.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
