Upstream Process Development Associate II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 50,000 - 70,000; 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 CHO mammalian cell lines, supporting process development, scale-up, and technology transfer to cGMP manufacturing.

The role requires a Bachelor's degree with 1–3+ years' experience or a Master's with 2+ years, strong knowledge of mammalian cell culture, and advanced MS Office skills. Weekend/holiday hours may apply with premium pay.

Qualifications

• Bachelor’s degree 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 proficiency with Microsoft Office (Excel, PowerPoint and Word).

Responsibilities

• Set up, operate, and analyze cell culture and bioreactor processes including bioreactor preparation, inoculation, sampling, feeding, data entry and data analysis.
• Lead in maintaining and monitoring process development experiments in shake flasks and bioreactors.
• Perform calculations for growth rate, specific productivity, and bioreactor scale-up/down.
• Assist in data analysis and writing of technical documents and reports.
• Maintain batch sheets and data binders following GDP.
• Assist in process transfer from development to manufacturing.

Skills

Mammalian cell culture

MS Office proficiency

Education

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

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

Tools

Design Expert (DOE)

JMP

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

EEO/AA

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. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.