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Upstream Process Development Jobs in North Carolina

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

$180 - $240/hr

Must have demonstrated biologics expertise in upstream or downstream processing and operations Must have experience in collaborating with process development, quality, supply chain, engineering and ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC

Must have demonstrated biologics expertise in upstream or downstream processing and operations * Must have experience in collaborating with process development, quality, supply chain, engineering and ...

KBI Biopharma, Inc.

Senior Director, MS&T

Durham, NC · On-site

Must have demonstrated biologics expertise in upstream or downstream processing and operations * Must have experience in collaborating with process development, quality, supply chain, engineering and ...

Amgen

Sr Mgr Engineering

Holly Springs, NC · On-site

$90K - $124K/yr

In this vital role you will provide scientific and technical leadership within the Process Development upstream group at Amgen's Flex Batch Biologics Manufacturing Facility. This role will be ...

Upstream Rehabilitation

Physical Therapist

Surf City, NC · On-site

$1.3K - $1.7K/wk

Continue learning and growing through Upstream's education and development programs Qualifications ... Specific details will be provided during the hiring process. time, or PRN). Specific details will ...

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Upstream Process Development information

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$17

$24

$34

How much do upstream process development jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for upstream process development in North Carolina is $24.10, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $25.34 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in upstream process development?

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 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 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.
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Upstream Process Development jobs near you
Infographic showing various Upstream Process Development job openings in North Carolina as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 15% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $50,121 per year, or $24.1 per hour.

Manager Manufacturing Programs - Process Owner Team

Amgen, Inc.

Holly Springs, NC • On-site

Full-time

Posted 25 days ago

Job description

Career Category
Manufacturing
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. Be part of Amgen North Carolina's newest and most advanced drug substance manufacturing facility, combining single-use technologies, traditional processing equipment, Industry 4.0 capabilities, and sustainability innovations.
Manager Manufacturing Programs - Process Owner Team
Live
What You Will Do
In this vital role, you will lead a team of Process Owners within the Manufacturing Support organization at Amgen North Carolina (ANC). This position may lead either an Upstream & Services-focused team or a Downstream-focused team and requires strong technical expertise in the applicable manufacturing area combined with demonstrated people leadership capabilities.
The Process Owner Team serves as a critical technical interface between Manufacturing Operations and support organizations, ensuring manufacturing processes are effectively translated into operational execution, manufacturing procedures, and digital manufacturing workflows. The team provides technical process stewardship, manufacturing floor support, operational readiness, CAPA implementation support, manufacturing change management, and procedural governance to enable safe, compliant, and reliable manufacturing operations.
  • Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.

  • Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.

  • Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities.

  • Ensure Process Owners provide effective floor support, hypercare, troubleshooting assistance, and manufacturing execution support.

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

  • Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.

  • Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).

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

  • Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives.

  • Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements.

  • Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks.

  • Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections.

Win
What We Expect of You
Basic Qualifications
  • Doctorate degree OR

  • Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR

  • Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR

  • Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR

  • High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience

  • In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications
  • 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility.

  • Demonstrated people leadership experience managing, coaching, and developing technical teams.

  • Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations.

  • Experience with GMP manufacturing operations, process stewardship, and manufacturing support.

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

  • Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support.

  • Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations.

  • 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.

  • Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities.

  • Strong communication, organizational, and cross-functional leadership 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
USD - USD

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