ZipRecruiter

Log In

1

Downstream Process Development Jobs in Apex, NC (NOW HIRING)

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 ...

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 ...

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 ...

AskBio

Process Engineer II

Durham, NC · On-site

... and downstream biomanufacturing operations, including process scale-up, technology transfer, process characterization, and process control strategy development * Continuous improvement-oriented ...

previous pagenext page

Showing results 21-40

All JobsDownstream Process Development JobsDownstream Process Development Jobs in Apex, NC

Downstream Process Development information

See Apex, NC salary details

$14

$25

$37

How much do downstream process development jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for downstream process development in Apex, NC is $25.66, according to ZipRecruiter salary data. Most workers in this role earn between $21.06 and $31.49 per hour, depending on experience, location, and employer.

What is downstream process development?

A Downstream Process Development job involves optimizing and scaling purification processes for biologics, such as proteins, antibodies, or gene therapies. Scientists and engineers in this role develop efficient methods for isolation, purification, and formulation of therapeutic products while ensuring quality and regulatory compliance. Key activities include chromatography, filtration, and process analytics to improve yield, purity, and consistency. This role is critical in biotech and pharmaceutical industries to ensure safe and effective drug production for clinical and commercial use.

What does someone in downstream process development do?

Professionals in Downstream Process Development are typically responsible for designing, optimizing, and scaling up purification processes for biopharmaceutical products. Their day-to-day work may involve conducting laboratory experiments, analyzing data, troubleshooting technical issues, and documenting process changes in accordance with regulatory standards. They also frequently collaborate with upstream processing, analytical, and quality teams to ensure seamless transfer and integration of processes. The role often includes participating in project meetings, contributing to process validation efforts, and supporting technology transfer to manufacturing teams, making it both technically challenging and collaborative.

What are the key skills and qualifications needed for downstream process development?

To excel in Downstream Process Development, you generally need a strong background in biochemistry, chemical engineering, or a related life sciences field, often with experience in bioprocessing or purification technologies. Familiarity with chromatography systems, filtration equipment, process analytical technology (PAT), and relevant software such as DeltaV or Unicorn is frequently required, along with knowledge of GMP and regulatory standards. Excellent problem-solving, project management, and cross-functional communication skills help professionals succeed in dynamic team environments. These competencies are crucial for developing efficient, scalable purification processes that ensure high product quality and support organizational goals.

Downstream Process Development jobs near you
Infographic showing various Downstream Process Development job openings in Apex, NC as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 18% Part Time, and 4% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $53,383 per year, or $25.7 per hour.

Specialist Manufacturing Process Owner - Upstream / Downstream / Services

Holly Springs, NC • On-site

Amgen SA
See more jobs at Amgen SAexternal

Other

Posted 10 days ago

Key responsibilities

  • Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.

  • Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first‑time executions.

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

Job description

Specialist Manufacturing – Process Owner - Upstream / Downstream / Services (Multiple Positions)

How we might 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.

What You Will Do

  • Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.

  • Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first‑time executions.

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

  • Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.

  • Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.

  • Support manufacturing‑related change controls associated with process, equipment, procedural, and operational improvements.

  • Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.

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

  • Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.

  • Participate in root cause analysis (RCA) activities and provide technical process expertise to support manufacturing investigations, major deviations, and quality events.

  • Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.

  • Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.

  • Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and Bill of Material (BOM) alignment, including single-use assemblies and consumables.

  • Support MES and EBR activities by providing process expertise and manufacturing representation.

  • Participate in inspection readiness activities and support audits as required.

  • Appropriately escalated process, operational, quality, and compliance concerns.

What We Expect of You Basic Qualifications

  • Doctorate degree and 2 years of biotechnology operations experience

  • Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience

  • Bachelor's degree and 6 years of biotechnology operations experience

  • Associate's degree and 10 years of biotechnology operations experience

  • High school diploma / GED and 12 years of biotechnology operations experience

Preferred Qualifications

  • Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

  • Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations.

  • Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment.

  • Experience supporting manufacturing floor operations, troubleshooting, and hypercare activities.

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

  • Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures.

  • Experience supporting manufacturing change controls and implementation activities.

  • Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities.

  • Experience supporting CAPA applicability assessments and effectiveness checks.

  • 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.

  • Strong technical writing, communication, problem‑solving, and organizational 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.

#J-18808-Ljbffr

Apply