Specialist Manufacturing Process Owner - Upstream / Downstream / Services

BioSpace; Holly Springs (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

Amgen NC facility in North Carolina is seeking a Specialist Manufacturing Process Owner to lead process stewardship across upstream, downstream, and services. You will partner with Manufacturing Operations, Process Development, and Supply Chain to ensure compliant, efficient production and continuous improvement.

You will own processes, provide floor support, and contribute to readiness activities, CAPA, and risk management while advancing industry 4.0 and sustainability goals.

Qualifications

• Doctorate or equivalent with biotechnology operations experience
• Advanced degrees with 4+ years biotech operations experience or higher
• Bachelor's with 6+ years biotech operations experience or more
• Proven experience supporting GMP manufacturing environments
• Experience authoring/maintaining GMP documentation and change controls

Responsibilities

• Serve as Process Owner for assigned manufacturing processes, equipment and unit operations.
• Provide floor support, troubleshooting, and hypercare during manufacturing operations.
• Support readiness activities including water runs, dry runs, equipment testing and EBR validation.
• Develop and maintain GMP documentation, SOPs, and manufacturing procedures.
• Assist with risk assessments, RCA investigations, and CAPA implementation.

Skills

GMP operations

Manufacturing floor support

Root cause analysis

Process optimization

Education

Doctorate degree in biotechnology

Master's degree in Engineering/Biology/Chemistry/Biochemistry

Bachelor's degree in biotechnology

Associate's degree in biotechnology

High school diploma / GED

Tools

MES

Electronic Batch Records (EBR)

GMP documentation

SOPs

CAPA

Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youveworked 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 Process Owner - Upstream / Downstream / Services (Multiple Positions)

Live

What You Will Do

• In this vital role, you will serve as a Process Owner within the Manufacturing Support organization atAmgenNorth Carolina (ANC). The Process Owner serves as a technical process steward and key interface between Manufacturing Operations and support organizations. This roleis responsible forsupporting manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.
• This position may support one of the following manufacturing areas depending on business needs and organizational assignment: Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).
• Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
• Provide manufacturing floor support, troubleshootingassistance, andhypercare 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) testingsupport.
• Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.
• Monitor process performance andidentifyopportunities for process optimization, operational improvement, and risk reduction.
• Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.
• Author, revise, review, andmaintainmanufacturing 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 processexpertiseto 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 processexpertiseand manufacturing representation.
• Participate ininspectionreadiness activities and support audits asrequired.
• Appropriately escalated process, operational, quality, and compliance concerns.

Win

What We Expect of You

Basic Qualifications

• Doctorate degree and 2 years of biotechnology operations experience OR
• Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR
• Bachelor's degree and 6 years of biotechnology operations experience OR
• Associate's degree and 10 years of biotechnology operations experience OR
• 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, andhypercare 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.