Upstream Process Development Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 50,000 - 70,000; Full time

Job summary

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

Responsibilities include set-up and operation of bioreactors from shake flasks to 200 L, data entry, and analysis of growth and productivity. The role requires a BS/MS with 1–3+ years in chemical engineering or biotechnology and strong MS Office skills.

Qualifications

• Bachelors plus 1–3+ years 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.
• Flexibility to support cell culture processes over weekends and holidays (premium pay).

Responsibilities

• Assist set-up, operation, and analysis of cell culture and bioreactor processes including preparation, inoculation, sampling, feeding, data entry and data analysis forshake flasks and various scale bioreactors.
• Lead in maintaining experiments and perform calculations for growth rate and productivity.
• Perform data entry, plotting, and support writing of technical reports using MS Office.
• Maintain batch sheets and data binders following GDP.
• Assist in data analysis using DOE (Design Expert) and JMP and help write technical documents.
• Maintain a cell culture project plan including raw materials and equipment availability for lab and pilot-scale runs.
• Participate in process development teams and coach junior staff on cell culture techniques.

Skills

Mammalian cell culture

MS Office proficiency

Independent and team work

Customer service

Weekend/holiday flexibility

Education

Bachelor’s degree in Chemical Engineering or Biotechnology

Master’s degree in Chemical Engineering or Biotechnology

Tools

Design Expert (DOE)

JMP

MS Office (Excel, PowerPoint, Word)

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-$70,000

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.