Process Development Associate I​/II

Job Summary

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.

• Conduct 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 (Tube Spins, Ambr
  15, Ambr
  250, 3 L & 15 L glass bioreactors, Wave, 50 L and 200 L Xcellerex single‑use bioreactors).
• Perform calculations for growth data, specific productivity, bioreactor agitation, and gassing scale‑up/scale‑down. Assist in data analysis using statistical software such as Design Expert (DOE), JMP, etc. Identify and troubleshoot 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 notebook entries with shake flask and bioreactor test results following good documentation practices (GDP).
• Maintain a cell‑culture–specific project plan, including raw materials and equipment availability, in preparation for laboratory and pilot‑scale runs.
• Support process transfer from process development to manufacturing.
• Contribute to the evaluation, development, and implementation of new upstream technologies that lead to process improvements and operational efficiency in support of upstream process development and manufacturing activities.
• Contribute to general lab maintenance, equipment troubleshooting, and operational excellence initiatives in accordance with internal guidance. Assure proper labeling, handling, and storage of all chemicals used in the area; assure proper labeling and disposition of hazardous waste in satellite areas; adhere to all safety requirements and follow safe procedures, and attend all required safety and health training, including handling hazardous waste.

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. 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.

• Ability to lift up to 40‑50 lbs, occasionally.

• MS Teams, Outlook, Word, proficiency in Excel, and PowerPoint.
• Computer, telephone, lab equipment usage.

Process Development Associate I: $55,000‑$75,900 per year.
Process Development Associate II: $63,000‑$86,900 per year.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc.

has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.