Upstream Process Development Associate I/II

KBI Biopharma, Inc.; North Carolina; On-site; USD 50,000 - 77,000; Full time

Job summary

KBI Biopharma, Inc. seeks an Upstream Cell Culture Process Development Associate to lead and assist in cell culture and harvest projects for mammalian CHO cell lines, supporting process development, scale-up, and tech transfer to cGMP manufacturing.

The role requires operation of bioreactors, data entry, generation of presentations, and maintaining detailed batch records. Collaboration with teams and supporting weekend/holiday shifts are part of the job.

Qualifications

• Bachelor’s degree and 1–3+ years’ experience, or master’s degree with 2+ years’ experience in Chemical Engineering, Biotechnology or related field.
• Working knowledge of mammalian cell culture.
• Advanced ability with Microsoft Office (Excel, PowerPoint and Word).

Responsibilities

• Assist in the set-up, operation, and analysis of cell culture and bioreactor processes including bioreactor preparation, inoculation, sampling, feeding, data entry, and data analysis for shake flasks and bioreactors.
• Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors, including growth rate and productivity calculations.
• Perform data entry and plotting, generate presentations and support writing of technical reports using MS Office.
• Maintain detailed batch sheets and data binders with test results following GDP.
• Assist in data analysis using statistical software and help with writing technical documents.
• Maintain a cell culture-specific project plan including materials and equipment availability for lab runs.
• Participate on process development teams and coach junior individuals on cell culture techniques.
• Interact with clients to present data and support projects from start to finish.
• Assist in process transfer from development to manufacturing.
• Experience in medium development will be a plus.

Skills

Mammalian cell culture

Microsoft Office

Data analysis

Teamwork

Customer service

Weekend availability

Education

Bachelor’s degree in Chemical Engineering, Biotechnology or related area

Master’s degree in Chemical Engineering, Biotechnology or related area

Job description

Position Summary:

KBI Biopharma seeks to fill a role for Upstream Cell Culture Process Development Associate. This person will lead and assist in cell culture and harvest projects for mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.

Position Responsibilities:

• 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 rate, specific productivity, and 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.
• Experience in medium development will be a plus

Position Requirements:

• Bachelor’s and 1-3+ years’ experience, or master’s degree and 2+ years’ experience in Chemical Engineering, Biotechnology or related area.
• Working knowledge of mammalian cell culture.
• Advanced ability with Microsoft Office (Excel, PowerPoint and Word).
• 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 in addition to base salary.

Salary:

$50,000-$77,000

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.