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Upstream Process Development Jobs in Raleigh, NC

PD Sr Engineer

Holly Springs, NC · On-site

$90K - $124K/yr

... process development, process engineering, or process validation experience OR * Doctorate degree Preferred Qualifications: * 5+ years of experience in an Upstream (Cell Culture), downstream ...

PD Sr Engineer

Holly Springs, NC · On-site

$90K - $124K/yr

... process development, process engineering, or process validation experience OR * Doctorate degree Preferred Qualifications: * 5+ years of experience in an Upstream (Cell Culture), downstream ...

Senior Process Engineer, MSAT

Durham, NC · On-site

$100K - $130K/yr

Experience in monoclonal antibody production and purification process development * Technical expertise upstream / downstream operations (both are preferable) including equipment knowledge and ...

Senior Process Engineer, MSAT

Durham, NC

$100K - $130K/yr

Experience in monoclonal antibody production and purification process development * Technical expertise upstream / downstream operations (both are preferable) including equipment knowledge and ...

Bachelor's degree and 2 years of biologics process development or process validation support experience OR * Master's degree Preferred Qualifications: * 2+ years of experience in an Upstream (Cell ...

Bachelor's degree and 2 years of biologics process development or process validation support experience OR * Master's degree Preferred Qualifications: * 2+ years of experience in an Upstream (Cell ...

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Upstream Process Development information

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How much do upstream process development jobs pay per hour?

As of Aug 3, 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 jobs pay 500,000 a year in the US?

In the field of Upstream Process Development, senior roles such as Director or Vice President can reach or exceed $500,000 annually, especially with bonuses and stock options. These positions typically require extensive experience, advanced degrees, and leadership skills in biopharmaceutical or biotech industries. High compensation is often associated with managerial responsibilities, strategic decision-making, and overseeing large teams or projects.

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 common upstream jobs?

Common upstream process development jobs include roles such as upstream process scientist, bioprocess engineer, and fermentation scientist. These positions focus on developing and optimizing the early stages of biopharmaceutical production, often requiring knowledge of cell culture, bioreactor operation, and process scale-up. Skills in laboratory techniques, process analytical technology, and regulatory compliance are also important in these roles.

What biology jobs pay over $100k?

In upstream process development, senior roles such as Process Development Managers, Principal Scientists, and Regulatory Affairs Directors often have salaries exceeding $100,000. These positions typically require advanced degrees, extensive industry experience, and expertise in bioprocessing, quality control, or regulatory compliance.

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 is upstream process development?

Upstream process development involves designing and optimizing the initial stages of biopharmaceutical production, such as cell culture and fermentation, to produce target biological products. It requires knowledge of bioprocessing, cell biology, and often involves working with bioreactors and process control systems to ensure consistent, high-quality output.

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 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:
Infographic showing various Upstream Process Development job openings in Raleigh, NC as of July 2026, with employment types broken down into 88% Full Time, 6% Part Time, and 6% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution, with an average salary of $53,611 per year, or $25.8 per hour.

Specialist Manufacturing - Process Owner - Upstream / Downstream / Services

Amgen, Inc.

Holly Springs, NC • On-site

$63K - $84K/yr

Full-time

Posted 23 days ago


Job description

Career Category
Manufacturing
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Specialist Manufacturing - Process Owner - Upstream / Downstream / Services (Multiple Positions)
Live
What You Will Do
In this vital role, you will serve as a Process Owner within the Manufacturing Support organization at Amgen North Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This role is responsible for supporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.
This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).
  • Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.

  • Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first-time executions.

  • Support operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.

  • Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.

  • Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.

  • Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.

  • Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.

  • Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.

  • Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.

  • Participate in root cause analysis (RCA) activities and provide technical process expertise to support manufacturing investigations, major deviations, and quality events.

  • Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.

  • Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.

  • Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material (BOM) alignment, including single-use assemblies and consumables.

  • Support MES and EBR activities by providing process expertise and manufacturing representation.

  • Participate in inspection readiness activities and support audits as required.

  • Appropriately escalate process, operational, quality, and compliance concerns.

Win
What We Expect of You
Basic Qualifications
  • Doctorate degree and 2 years of biotechnology operations experience OR

  • Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR

  • Bachelor's degree and 6 years of biotechnology operations experience OR

  • Associate's degree and 10 years of biotechnology operations experience OR

  • High school diploma / GED and 12 years of biotechnology operations experience

Preferred Qualifications
  • Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

  • Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.

  • Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.

  • Experience supporting manufacturing floor operations, troubleshooting, and hypercare activities.

  • Experience supporting operational readiness activities including water runs, dry runs, equipment testing, and startup support.

  • Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.

  • Experience supporting manufacturing change controls and implementation activities.

  • Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities.

  • Experience supporting CAPA applicability assessments and effectiveness checks.

  • Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment.

  • Knowledge of single-use technologies and Bill of Material (BOM) structures.

  • Strong technical writing, communication, problem-solving, and organizational skills.

Thrive
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being through comprehensive benefits, career development opportunities, and a collaborative culture.
Salary Range
107,545.40USD -145,502.60 USD