Not Authorized
You are currently not authorized to access this section.
Please contact your Administrator to change your authorization settings.
Please contact your Administrator to change your authorization settings.
Process Development Associate-Upstream #848
Durham, NC
Job Description
About KBI Biopharma:
KBI Biopharma is a fast-growing, Science-Driven and Customer-Focused contract development & manufacturing organization (CDMO) serving the global biopharmaceutical industry. KBI’s business model is designed from the ground up to help clients accelerate their path to market while reducing risk and building value. Our customers range from small biotech to global biopharmaceutical companies as well as academic and non-profit organizations. In every client testimonial we’ve received and in every client survey we’ve seen, we are proud to report that KBI is viewed as the most collaborative and responsive of all the CDMOs with whom our clients work.
KBI has an extensive track record of success in developing robust and scalable processes for cGMP manufacturing for a wide range of recombinant proteins for our clients. The Company has proven expertise in developing upstream and downstream processes, analytics and formulations, scale-up, technology transfer, and cGMP manufacture of protein-based therapeutics for pre-clinical and clinical manufacturing, process optimization and characterization, process performance qualification, and commercial launch production. To date, we have served over 250 clients globally. KBI was named Company of the Year at Triangle Business Journal's Life Sciences Awards in 2018.
The mammalian cell culture laboratories and pilot-scale operations are state-of-the-art. Single-use bioreactors ranging from 15 mL to 200 L are employed for process development and tech transfer projects. Well characterized ambr15 and ambr250 bioreactors from Sartorius along with the Xcellerex Single-use bioreactors (XDR-50 and XDR-200) are used as the mainstay of mammalian cell culture process development at KBI. High throughput equipment like Bio HT (Roche), Vi-CELL and blood gas analyzers are used for offline testing of cell culture samples.
Job Description:
KBI Biopharma seeks to fill a role for Cell Culture Process Development Associate. This person will lead and assist in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.
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.
KBI Biopharma is a fast-growing, Science-Driven and Customer-Focused contract development & manufacturing organization (CDMO) serving the global biopharmaceutical industry. KBI’s business model is designed from the ground up to help clients accelerate their path to market while reducing risk and building value. Our customers range from small biotech to global biopharmaceutical companies as well as academic and non-profit organizations. In every client testimonial we’ve received and in every client survey we’ve seen, we are proud to report that KBI is viewed as the most collaborative and responsive of all the CDMOs with whom our clients work.
KBI has an extensive track record of success in developing robust and scalable processes for cGMP manufacturing for a wide range of recombinant proteins for our clients. The Company has proven expertise in developing upstream and downstream processes, analytics and formulations, scale-up, technology transfer, and cGMP manufacture of protein-based therapeutics for pre-clinical and clinical manufacturing, process optimization and characterization, process performance qualification, and commercial launch production. To date, we have served over 250 clients globally. KBI was named Company of the Year at Triangle Business Journal's Life Sciences Awards in 2018.
The mammalian cell culture laboratories and pilot-scale operations are state-of-the-art. Single-use bioreactors ranging from 15 mL to 200 L are employed for process development and tech transfer projects. Well characterized ambr15 and ambr250 bioreactors from Sartorius along with the Xcellerex Single-use bioreactors (XDR-50 and XDR-200) are used as the mainstay of mammalian cell culture process development at KBI. High throughput equipment like Bio HT (Roche), Vi-CELL and blood gas analyzers are used for offline testing of cell culture samples.
Job Description:
KBI Biopharma seeks to fill a role for Cell Culture Process Development Associate. This person will lead and assist in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing.
- Lead and 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 date, specific productivity, bioreactor agitation and gassing scale-up.
- 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).
- 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, research associates and interns, on cell culture techniques.
- 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.
- Bachelor’s, or Master’s degree in Chemical Engineering, Biotechnology or related area (or equivalent training) with 0-2+ years’ experience.
- Candidates to be considered for a Senior Process Development Associate role require degree as described and 5+ years’ experience (or Master’s and 2+ years’ experience).
- 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 in the salary.
- Experience with statistical design of experiment (DOE) is a plus.
- Ideal Candidate will have minimum of 2 years’ experience working with mammalian cell culture and bioreactors; and will have an in-depth understanding of biological and engineering factors that influence cell culture process performance and product quality.
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.
Job Summary
Company
Start Date
Immediately
Employment Term and Type
Regular, Full Time
Salary and Benefits
Competitive
Required Education
Bachelor's Degree
Required Experience
2 years
Email this Job to Yourself or a Friend