Upstream Process Development Associate I/II

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

Job summary

KBI Biopharma, Inc. is seeking an Upstream Cell Culture Process Development Associate to lead and assist in mammalian cell culture and harvest projects for CHO lines. This role supports process development, scale-up, and technology transfer to cGMP manufacturing.

The candidate will perform calculations for growth rate and productivity, manage batch data, and assist in data analysis using DOE and JMP. Occasional weekend work may be required as part of project timelines.

Qualifications

• BS in Chemical Engineering, Biotechnology or related field with relevant experience.
• Experience with mammalian cell culture and process development.
• Ability to analyze data and present results clearly.

Responsibilities

• Assist set-up, operation, and analysis of cell culture and bioreactor processes.
• Lead experiments in shake flasks and various scale bioreactors.
• Calculate growth rate, productivity, and scale-up parameters.
• Prepare data, plots, and reports using DOE tools and MS Office.
• Support process transfers to manufacturing and cross-team collaboration.

Skills

Mammalian cell culture knowledge

MS Office proficiency

Team player with strong communication

Education

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

Master’s degree with 2+ years of experience

Tools

Design Expert

JMP

Excel (advanced)

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 and Benefits

Salary: $50,000-$70,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.

• KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

Equal Opportunity Statement

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.

Company Culture

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.