Upstream Process Development Associate I/II

KBI Biopharma; North Carolina; On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401K matching with 100% vesting in 60d

Employee recognition programs

Job summary

KBI Biopharma seeks an Upstream Cell Culture Process Development Associate to 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.

Responsibilities include set-up and operation of cell culture and bioreactor processes, data entry and analysis, GDP documentation, and collaboration with process development teams.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biotechnology or related field with 1–3+ years (Bachelor) or 2+ years (Master).
• Experience with mammalian cell culture and basic data handling.

Responsibilities

• Set up, operate, and analyze cell culture and bioreactor processes (batches, sampling, data entry).
• Monitor and assist in growth, productivity calculations, and scale-up/down as needed.
• Prepare presentations and write technical reports using MS Office.
• Maintain batch sheets and GDP-compliant data binders.
• Assist in data analysis using DOE/JMP and help draft documents for transfer to manufacturing.
• Support process transfer from development to manufacturing.

Education

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

Tools

Microsoft Office

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

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.

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.