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Biotech Process Development Jobs in Raleigh, NC (NOW HIRING)

Amgen

Senior Process Engineer

Holly Springs, NC · On-site

$90K - $116K/yr

It is key to our becoming one of the world's leading biotechnology companies, reaching over10 ... This may include development of business case for improvement and identification of design ...

Astrix Inc

Manufacturing Associate

Holly Springs, NC · On-site

As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are ... Collaborate with cross-functional teams (Engineering, Process Development, and Quality Assurance ...

Amgen, Inc.

Senior Process Engineer

Holly Springs, NC · On-site

$90K - $116K/yr

It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 ... This may include development of business case for improvement and identification of design ...

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All JobsBiotech Process Development JobsBiotech Process Development Jobs in Raleigh, NC

Biotech Process Development information

See Raleigh, NC salary details

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How much do biotech process development jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for biotech process development in Raleigh, NC is $32.74, according to ZipRecruiter salary data. Most workers in this role earn between $26.88 and $40.19 per hour, depending on experience, location, and employer.

What is biotech process development?

Biotech process development refers to the design, optimization, and scale-up of manufacturing processes used to produce biological products, such as pharmaceuticals, enzymes, or vaccines. Professionals in this field work to turn laboratory procedures into efficient, large-scale industrial processes that meet regulatory and quality standards. This often involves selecting suitable equipment, optimizing conditions, ensuring reproducibility, and troubleshooting production issues. The ultimate goal is to produce high-quality products safely, consistently, and cost-effectively.

What are the key skills and qualifications needed to thrive in biotech process development, and why are they important?

To excel in Biotech Process Development, you need a strong background in bioprocess engineering, molecular biology, and chemistry, typically supported by a degree in biotechnology or related fields. Familiarity with tools such as bioreactors, chromatography systems, and data analysis software, along with certifications in Good Manufacturing Practice (GMP), is highly valuable. Strong problem-solving skills, attention to detail, and effective teamwork distinguish top performers in this role. These competencies are crucial for optimizing processes, ensuring product quality, and driving innovation in the biotech industry.

What are some common challenges faced by professionals in biotech process development, and how are they typically addressed?

Professionals in Biotech Process Development often encounter challenges related to scaling up processes from the laboratory to commercial production, ensuring product consistency, and meeting strict regulatory standards. Addressing these challenges typically involves close collaboration with cross-functional teams such as quality assurance, regulatory affairs, and manufacturing. Continuous process optimization, thorough documentation, and robust validation protocols are essential strategies to overcome these hurdles and ensure successful product development and commercialization.

What is the difference between Biotech Process Development vs Biotech Manufacturing Associate?

AspectBiotech Process DevelopmentBiotech Manufacturing Associate
Primary FocusDesigning, optimizing, and scaling up bioprocesses for product developmentExecuting manufacturing processes to produce biopharmaceuticals at scale
Work EnvironmentLaboratories and pilot plant facilitiesProduction floors and manufacturing plants
Required SkillsProcess design, lab techniques, troubleshootingEquipment operation, quality control, adherence to SOPs
Typical CredentialsBSc/MSc in Biotechnology, Chemical Engineering, or related fieldsBSc in Biotechnology, Biology, or related fields

While both roles are essential in biotech, Biotech Process Development focuses on creating and optimizing processes during product development, whereas Biotech Manufacturing Associates handle the day-to-day production to ensure consistent product quality at scale.

What are popular job titles related to Biotech Process Development jobs in Raleigh, NC?

For Biotech Process Development jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Biotech Process Development jobs in Raleigh, NC look for?

The top searched job categories for Biotech Process Development jobs in Raleigh, NC are:

Biotech Process Development jobs near you
Infographic showing various Biotech Process Development job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, and 5% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $68,104 per year, or $32.7 per hour.

Manager Manufacturing Programs Process Owner Team

Holly Springs, NC • On-site

Amgen SA
See more jobs at Amgen SAexternal

Other

Posted 26 days ago

Key responsibilities

  • Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.

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

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

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 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.
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, programs, or directing the allocation of 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.

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