Process Development Associate I/II

KBI Biopharma•Durham, NC

1d•$55,000 - $86,900

About The Position

The Upstream Process Development Associate participates in cell culture and harvest projects for mammalian cell lines in support of process development, scale-up, and technology transfer to cGMP manufacturing.

Requirements

Process Development Associate I requires a B.S. degree in biotechnology.
Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree.
Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines.
Flexibility of hours to support upstream processes.

Nice To Haves

Knowledge of GMPs and biotechnology-derived product regulations preferred.
Experience in cell culture development, medium development or pilot-scale bioreactor operations is preferred.
Experience using electronic lab notebooks and/or PI historian is a plus.

Responsibilities

Conducts laboratory experiments in support of upstream processes including the set-up, operation, and associated analysis of cell culture and bioreactor processes. This involves bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis for shake flask and various scale bioreactors (TubeSpins, Ambr15, Ambr250, 3 L & 15 L glass bioreactors, Wave, 50 L and 200 L Xcellerex single-use bioreactors).
Performs calculations for growth data, specific productivity, bioreactor agitation and gassing scale up/scale down.
Assist in data analysis using statistical software like Design Expert (DOE), JMP etc.
Identifies and troubleshoots unexpected results with input and/or review from peers or management.
Perform data entry and plotting, generate presentations, and support writing of technical reports.
Maintain detailed electronic lab notebooks entries with shake flask and bioreactor test results following good documentation practices (GDP).
Maintains a cell culture-specific project plan, including raw materials and equipment availability, in preparation of laboratory and pilot- scale runs.
Support process transfer from process development to manufacturing.
May contribute to the evaluation, development and implementation of new upstream technologies leading to process improvements and efficiency of operation in support of upstream process development and manufacturing activities.
Contributes to general lab maintenance, equipment troubleshooting, and operational excellence initiatives in accordance with internal guidance.
Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.