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Upstream Process Development Jobs in Raleigh, NC

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Process Engineer Pharmaceuticals I

NC · On-site

This role is execution-focused, supporting upstream and downstream manufacturing operations, routine experiments, and process development studies working in close coordination with manufacturing and ...

AskBio

Process Engineer II

Durham, NC · On-site

... upstream and downstream biomanufacturing operations, including process scale-up, technology transfer, process characterization, and process control strategy development * Continuous improvement ...

AskBio

Process Engineer II

Durham, NC

... upstream and downstream biomanufacturing operations, including process scaleup, technology transfer, process characterization, and process control strategy development * Continuous ...

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How much do upstream process development jobs pay per hour?

As of May 29, 2026, the average hourly pay for upstream process development in Raleigh, NC is $25.77, according to ZipRecruiter salary data. Most workers in this role earn between $22.88 and $27.12 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Upstream Process Development, and why are they important?

Success in Upstream Process Development requires a strong background in biology, biochemistry, or chemical engineering, often with an advanced degree and experience in cell culture or fermentation techniques. Familiarity with bioreactors, process control systems, and analytical instrumentation, as well as knowledge of cGMP regulations, is essential. Critical thinking, problem-solving, and effective communication are important soft skills for optimizing processes and collaborating across multidisciplinary teams. These competencies ensure efficient development of scalable production processes, maintaining product quality and regulatory compliance.

What are some common challenges faced in upstream process development and how do teams typically address them?

One of the main challenges in upstream process development is optimizing cell culture conditions to consistently achieve high yields and product quality. Teams often encounter variability in biological systems and must troubleshoot issues such as contamination, scale-up inconsistencies, or nutrient limitations. Collaboration with analytical, downstream, and quality teams is essential to identify root causes and implement solutions. Regular data review meetings, cross-functional problem-solving, and continuous process improvement are standard practices to ensure robust upstream processes.

What is upstream process development?

Upstream process development refers to the optimization and scaling of biological production processes that occur before product harvesting. This primarily involves the cultivation of cells or microorganisms to produce a desired product, such as a protein or antibody, in bioreactors. Scientists in this field work on improving cell lines, culture media, and fermentation conditions to maximize yield and quality. Upstream process development is a critical early phase in biomanufacturing, laying the foundation for downstream processing and overall production efficiency.

What is the difference between Upstream Process Development vs Downstream Process Development?

AspectUpstream Process DevelopmentDownstream Process Development
FocusDevelopment of cell culture, fermentation, and bioreactor processesPurification, filtration, and formulation of bioproducts
Skills & CredentialsBioprocess engineering, molecular biology, biochemistryBioprocessing, chromatography, analytical chemistry
Work EnvironmentLaboratories, bioreactors, pilot plantsPurification facilities, labs, quality control
Industry UsageBiotech, pharmaceutical manufacturingBiotech, pharmaceutical manufacturing

Upstream Process Development focuses on creating and optimizing cell culture and fermentation processes to produce bioproducts. In contrast, Downstream Process Development involves purifying and finishing these products. Both roles are essential in biopharmaceutical manufacturing and require similar scientific backgrounds, but they specialize in different stages of bioprocessing.

What are popular job titles related to Upstream Process Development jobs in Raleigh, NC? For Upstream Process Development jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Upstream Process Development jobs in Raleigh, NC look for? The top searched job categories for Upstream Process Development jobs in Raleigh, NC are:
Upstream Process Development jobs near you
Infographic showing various Upstream Process Development job openings in Raleigh, NC as of May 2026, with employment types broken down into 42% Full Time, 33% Part Time, 4% Temporary, and 21% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $53,611 per year, or $25.8 per hour.
Process Development Associate I/II

Process Development Associate I/II

KBI Biopharma, Inc.

Durham, NC • On-site

$55K - $75.90K/yr

Full-time

Posted 28 days ago

Job description

Job Summary:
The Upstream Process Development Associate participates in cell culture and harvest projects for mammalian cell lines in support of process development, scale-up, and technology transfer to cGMP manufacturing.
Primary Job Responsibilities:
  • Conducts laboratory experiments in support of upstream processes including the set-up, operation, and associated analysis of cell culture and bioreactor processes. This involves bioreactor preparation, autoclaving, inoculation, sampling, feeding, data entry, and data analysis for shake flask and various scale bioreactors (TubeSpins, Ambr15, Ambr250, 3 L & 15 L glass bioreactors, Wave, 50 L and 200 L Xcellerex single-use bioreactors).
  • Performs calculations for growth data, specific productivity, bioreactor agitation and gassing scale up/scale down. Assist in data analysis using statistical software like Design Expert (DOE), JMP etc. Identifies and troubleshoots unexpected results with input and/or review from peers or management.
  • Perform data entry and plotting, generate presentations, and support writing of technical reports. Maintain detailed electronic lab notebooks entries 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.
  • Support process transfer from process development to manufacturing.
  • May contribute to the evaluation, development and implementation of new upstream technologies leading to process improvements and efficiency of operation in support of upstream process development and manufacturing activities.
  • Contributes to general lab maintenance, equipment troubleshooting, and operational excellence initiatives in accordance with internal guidance. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.

Minimum Requirements:
Process Development Associate I requires a B.S. degree in biotechnology.
Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree.
Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Flexibility of hours to support upstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred. Experience in cell culture development, medium development or pilot-scale bioreactor operations is preferred. Experience using electronic lab notebooks and/or PI historian is a plus.
  • Physical Demands

Ability to lift up to 40-50 lbs, occasionally.
  • Computer Skills

MS Teams, Outlook, Word, Proficiency in Excel, and PowerPoint. Equipment Use
Computer, telephone, lab equipment.
Salary:
Process Development Associate I: $55,000-$75,900
Process Development Associate II: $63,000-$86,900
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.

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