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

IQVIA

CRA 1, IQVIA Biotech

Durham, NC

$71K - $119K/yr

... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...

IQVIA, Inc.

CRA 1, IQVIA Biotech

Durham, NC · On-site

$71K - $119K/yr

... processes or start-up activities based on study needs. Accurate and timely documentation is ... We create intelligent connections to accelerate the development and commercialization of innovative ...

IQVIA

CRA 1, IQVIA Biotech

Durham, NC · On-site

$71K - $119K/yr

... level financial processes or startup activities based on study needs. Accurate and timely ... We create intelligent connections to accelerate the development and commercialization of innovative ...

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How much do biotech process development jobs pay per hour?

As of Jun 18, 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 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 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 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

Specialist - Manufacturing Investigations

Amgen, Inc.

Holly Springs, NC • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 27 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 Investigations
Live
What you will do
Let's do this. Let's change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
  • Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.

  • Drive improvements to the investigation process.

  • Present investigations to regulatory inspectors, internal auditors, and management.

  • Clearly communicate investigation progress to impacted areas and leadership.

  • Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.

  • Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.

  • Build effective relationships across functions.

  • Navigate through ambiguity and provide a structured problem-solving approach.

  • Apply inductive and deductive reasoning in the investigation process

  • Clear and concise technical writing

  • Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.

  • Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications:
  • Doctorate degree OR
  • Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or
  • Bachelor's degree and 5 years of biotechnology operations experience or
  • Associate's degree & 10 years of biotechnology operations experience or
  • High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications:
  • 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility

  • Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.) critical thinking, project management, and quality systems.

  • Degree in Science or Engineering

  • Experience leading complex investigations

  • Experience using Veeva QMS for Deviation investigations and CAPAs

  • Demonstrated project management ability

  • Experience presenting to inspectors during regulatory inspections and internal audits.

  • Excellent written and verbal communication skills

  • Ability to work in a team matrix environment and build relationships with partners

  • Strong interpersonal skills

Thrive
What you can expect of us
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.
The annual base salary range for this opportunity in the U.S. is provided below.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements, where possible.

Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#AmgenNorthCarolina
Salary Range
107,545.40USD -145,502.60 USD

Apply