Process Development Associate - Upstream

Position Summary:

KBI Is looking for a Process Development Associate for our Upstream team. The mammalian cell culture laboratories and pilot-scale operations are state-of-the-art. Single-use bioreactors ranging from 15 mL to 200 L are employed for process development and tech transfer projects. Well characterized ambr15 and ambr250 bioreactors from Sartorius along with the Xcellerex Single-use bioreactors (XDR-50 and XDR-200) are used as the mainstay of mammalian cell culture process development at KBI. High throughput equipment like Bio HT (Roche), Vi-CELL and blood gas analyzers are used for offline testing of cell culture samples.

Position Responsibilities:

The Cell Culture Process Development Associate assists in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.

• 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 date, specific productivity, 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.

Minimum Requirements:

• Bachelors degree and 2 years of experience or a Masters and 0-2 years of experience in Chemical Engineering, Biotechnology or related area (or equivalent training)
• Working knowledge of mammalian cell culture
• 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 to the base salary.