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Upstream Process Development Jobs in Raleigh, NC

AskBio

Process Engineer II

Durham, NC · On-site

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

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 ...

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 ...

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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 24, 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?

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 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 common upstream process development jobs?

Common upstream process development jobs include roles such as upstream process scientist, process engineer, and bioprocess development specialist. These positions focus on optimizing cell culture, fermentation, and bioreactor processes to improve product yield and quality, often requiring knowledge of bioreactor operation, cell biology, and process scale-up. Skills in laboratory techniques, process modeling, and regulatory compliance are also important in these roles.

What is an upstream process development job?

An upstream process development job involves designing, optimizing, and scaling the early stages of biopharmaceutical production, such as cell culture and fermentation processes. Professionals in this role typically work with bioreactors, laboratory equipment, and process analytical tools to improve yield and quality of biological products. Strong knowledge of microbiology, biochemistry, and process engineering is essential, along with adherence to regulatory standards.

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 August 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.

Senior Manager Manufacturing Systems Engineering - Automation (Multiple Positions)

Amgen, Inc.

Holly Springs, NC • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 9 days ago

Job description

Career Category
Engineering
Job Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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.
We are hiring two Senior Manager, Manufacturing Systems Engineering positions, each with a distinct area of focus:
  • Senior Manager - Automation Systems: Responsible for leading and supporting Building Automation Systems (BAS/QBAS), Rockwell PLC platforms, Upstream Process Control Systems (PCS), and Clean Utility PCS.
  • Senior Manager - Manufacturing & Project Delivery: Responsible for New Product Introduction (NPI) delivery, project implementation, manufacturing shift floor support, and Downstream Process Control Systems (PCS).

Indicate area of interest and relevant experience as it aligns with one or both of these leadership opportunities.
Senior Manager Manufacturing Systems Engineering - Automation
What You Will Do
Let's do this. Let's change the world. In this role The Senior Manager is responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for administrating and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization.
As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering at Amgen North Carolina. This role is expected to provide leadership as follows:
  • Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC 1 manufacturing. Systems including Allen Bradley PLCs, Siemens Desigo CC for building automation, and Emerson DeltaV for process control.

  • Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing.

  • Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.

  • Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources.

  • Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.

  • Provid input into department objectives and establishing strategic direction within the Drug Substance Network for the F&E automation team.

  • Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on "Maintenance Excellence" systems failures and recurrence avoidance.

  • Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.

  • Identify areas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement.

  • Ensure site readiness and compliance for internal audits, external agency audits, and partner audits.

  • Ensure the safety of all personnel during plant operations and engineering activities.

  • Develop expense budget forecast and adhere to department budgets and spend for operational and capital expenses, holding 100% accountability.

  • Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

  • Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.

  • Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time (RFT) delivery of automation solutions.

  • Ensure that reporting functionality is incorporated for all unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.

  • Responsible for ensuring that service contracts with all OEMs for systems are established for service and support needs, including service banked hours for specialized support needs.

  • Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.

  • Ensure the automation staff are fully aware and confident to work on all automation systems, process equipment, and facility to provide 24x7 reliable plant automation support.

  • Responsible for ensuring that the automation team actively participates in daily/weekly Work Center Team (WCT) meetings - Manufacturing area & plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.

  • Responsible for ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.

  • Provide active leadership such that proactive feedback is solicited from the automation staff and actions are taken to maintain proper work-life balance.

What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The engineering management professional we seek will possess these qualifications.
Basic Qualifications:
  • High school diploma / GED and 12 years of Engineering and/or Project Management experience OR
  • Associate's degree and 10 years of Engineering and/or Project Management experience OR
  • Bachelor's degree and 8 years of Engineering and/or Project Management experience OR
  • Master's degree and 6 years of Engineering and/or Project Management experience OR
  • Doctorate degree and 2 years of Engineering and/or Project Management experience
  • Additionally: In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field

  • Experience with Emerson DeltaV DCS system, Siemens Desigo CC, Allen Bradley PLC and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies

  • Direct knowledge of automation system design

  • Experience in programming, installation and lifecycle management of automation and field instrumentation technologies

  • Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep

  • Experience in integrating various OEM automation software

  • Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.

  • Fieldbus, and Profibus technologies

  • Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95

  • Self-directed team player able to work cross-functionally

  • Strong leadership, technical writing, and communication 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.
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
#AmgenNorthCarolina
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.
Salary Range
163,288.40USD -220,919.60 USD

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