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Downstream Purification Jobs in Raleigh, NC (NOW HIRING)

Valspec

Process Validation Engineer

Raleigh, NC · On-site

$70 - $80/hr

Upstream (cell culture/bioreactors), Downstream (purification/chromatography), or Clean Utilities (WFI, clean steam, process gases, and supporting utility systems). This person will partner closely ...

Astrix Inc

Manufacturing Associate

Cary, NC · On-site

Perform downstream purification using AKTA chromatography systems. * Monitor process parameters and ensure compliance with SOPs and quality standards. * Support batch documentation and data recording.

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Downstream Purification information

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$13

$24

$33

How much do downstream purification jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for downstream purification in Raleigh, NC is $24.25, according to ZipRecruiter salary data. Most workers in this role earn between $19.62 and $28.03 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in downstream purification, and why are they important?

To excel in Downstream Purification, you need a solid background in biochemistry or chemical engineering, with experience in protein purification techniques and a relevant degree. Familiarity with chromatography systems (e.g., AKTA), filtration technologies, and good manufacturing practice (GMP) certification is highly valuable. Strong analytical thinking, attention to detail, and effective teamwork are important soft skills in this role. These competencies ensure the efficient and reliable production of high-purity biopharmaceutical products, critical for product quality and regulatory compliance.

What are some common challenges faced in a downstream purification role, and how can they be addressed?

Professionals in Downstream Purification often encounter challenges such as maintaining product yield and purity, troubleshooting equipment malfunctions, and adapting to process variability. Addressing these requires strong analytical skills, attention to detail, and close collaboration with upstream teams and quality assurance. Continuous training on the latest purification technologies and strict adherence to standard operating procedures also help minimize errors and improve efficiency in the production process.

What is the difference between Downstream Purification vs Downstream Processing?

AspectDownstream PurificationDownstream Processing
FocusPurifying specific products from a mixtureOverall process including purification and initial recovery
CredentialsTypically requires bioprocessing or biotech certificationsSimilar credentials, often overlapping
Work EnvironmentLaboratories, clean rooms, manufacturing facilitiesLabs and production plants
Industry UsageBiotech, pharmaceutical manufacturingBiotech, pharmaceutical, and bioprocessing industries

Downstream Purification is a specialized part of the broader Downstream Processing. While downstream processing includes all steps from initial product recovery to purification, downstream purification specifically focuses on isolating and purifying the target product. Both roles often require similar skills and certifications, and they operate in comparable environments within biotech and pharmaceutical industries.

What are popular job titles related to Downstream Purification jobs in Raleigh, NC? For Downstream Purification jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Downstream Purification jobs in Raleigh, NC look for? The top searched job categories for Downstream Purification jobs in Raleigh, NC are:
Downstream Purification jobs near you
Infographic showing various Downstream Purification job openings in Raleigh, NC as of August 2026, with employment types broken down into 87% Full Time, 6% Part Time, 6% Contract, and 1% Nights. Highlights an 82% Physical, 5% Hybrid, and 13% Remote job distribution, with an average salary of $50,441 per year, or $24.3 per hour.

Senior Manager: Manufacturing- Downstream Bulk Drug Substance

Amgen

Holly Springs, NC • On-site

Full-time

Posted 16 days ago

Job description

Career CategoryManufacturingJob Description

HOW MIGHT YOU DEFY IMAGINATION?

You'veworked 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 over10 million patientsworldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The AmgenFleXBatch facility combines the latest insingleusetechnologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager: Manufacturing- DownstreamBulk Drug Substance

Live

What youwill do

Let'sdo this.Let'schange the world. As Senior Manager of Manufacturing, you will provide leadership and guidance to the team responsible for 24/7 manufacturing operations in downstream purification.

In this vital role as a member of the Manufacturing Leadership Team, the Senior Manager of Manufacturing will collaborate cross-functionally to enable the commissioning, qualification, start-up, and GMP operation of a new drug substance manufacturing facility. This roleis responsible forcoaching and developing Downstream Front-Line Managers who oversee staff supporting direct drug substance production.

The Senior Manager will be accountable for the organizational design of the manufacturing team, including workforce planning, hiring, onboarding, training, qualification, and development of staff to support safe, reliable, and compliant operations. The role will ensure that personnel are appropriately trained and qualifiedin accordance withestablished training programs, procedures, and operational readiness requirements.

The position will provide leadership and manufacturing oversight for Commissioning and Qualification activities associated with downstream process systems, equipment, utilities, and supporting infrastructure. Responsibilities will include partnering with Engineering, Quality, Automation, Validation, Process Development, and project teams to review system designs, commissioning and qualification protocols, acceptance criteria, turnover packages, and supporting documentation to confirm that systems are safe, compliant, maintainable, and operationally ready.

The Senior Manager will ensureappropriate Manufacturingparticipation in design reviews, system walkdowns, factory and site acceptance testing, commissioning execution, equipment qualification, process demonstrations, water runs, engineering runs, and performance qualification activities. The role will also support the identification, documentation, escalation, and resolution of equipment, process, automation, and facility issuesidentifiedduring C&Q and start-up. The position will also provide leadership and oversight for downstream chromatography column packing activities to ensure readiness for reliable GMP operations.

Additionally, the Senior Manager will lead operational readiness activitiesrequiredfor successful facility start-up and transition to routine GMP manufacturing. This includes development and execution of readiness plans, establishment of operating procedures and standard work, completion of training and qualification activities, confirmation of materials and equipment availability, implementation of shift structures, and verification that manufacturing systems and support processes are prepared for operation.

The position willestablishand monitor readiness metrics, risks, dependencies, and action plans, ensuring that gaps areidentifiedearly, assigned to accountable owners, and resolved in alignment with project and manufacturing milestones. The Senior Manager will also ensure effective handover of qualified systems from the project organization to Manufacturing andestablishsustainable processes for equipment ownership, system performance monitoring, troubleshooting, preventive maintenance coordination, and continuous improvement.

Following facility start-up, the Senior Manager will be accountable for sustained manufacturing performance, including safety, quality, compliance, schedule adherence, operational reliability, workforce capability, and continuous improvement across downstream purification operations.

Responsibilities:

  • Develop andretaina diverse and high performing team in alignment with operational readiness schedules to ensure successful startup and commercial GMP operations

  • Mature the site's safety and quality culture of the department and champion continued improvement

  • Collaborate as one team of all manufacturing support groups (Quality, Process Development, Engineering, Supply Chain, and network partners)

  • Provide support to troubleshoot,identify, and resolve issues as needed and manage call coverage for 24/7 operation

  • Provide technical leadership for the investigation of deviations and the development of corrective actions

  • Develop and implement departmental strategy and plans that are aligned with the broader organizational strategy and deliver continuous improvement

  • Provide leadership and oversight for downstream chromatography column packing activities, including planning, execution, qualification, troubleshooting, documentation, and readiness to support reliable GMP manufacturing operations.

  • Lead and support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections

  • Deliver against organizational financial commitments while championing a lean philosophy

  • Provide Manufacturing leadership and support for Commissioning and Qualification activities, including design reviews, system walkdowns, protocol execution, issue resolution, and equipment turnover

  • Lead operational readiness activities for downstream manufacturing, including procedures, training, staffing, materials, system ownership, and readiness assessments to support successful facility start-up and transition to GMP operations.

Win

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. The experienced professional weseekis a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Manufacturing & Operations experience Or

Master's degree and 6 years of Manufacturing & Operations experience Or

Bachelor's degree and 8 years of Manufacturing & Operations experience Or

Associate's degree and 10 years of Manufacturing & Operations experience Or

High School diploma/GED and 12 years of Manufacturing & Operations experience

AND2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

  • Demonstrated managerial experience in a GMP manufacturingdrug substanceplant

  • Demonstrated experience in applying Operational Excellence and Lean Manufacturing

  • Cross-functional work experience in either Process Development, Quality or Engineering

  • Excellent communication skills, drive, sense of urgency, energyleveland problem-solving abilities

  • Demonstrated ability to forge andmaintainstrong relationships with other functional areas

  • Ability to effectively develop and coach staff and positively advance the culture of an organization

Thrive

What you can expectofus

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.

  • Vast opportunities to learn and move up and across our global organization

  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plancomprisinghealth, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patientsabove all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

#AmgenNorthCarolina

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Salary Range

136,227.80USD -184,308.20USD

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