Specialist Manufacturing Process Owner - Upstream / Downstream / Services

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Amgen in North Carolina is seeking a Specialist Manufacturing Process Owner to lead technical ownership of core manufacturing processes across Upstream, Downstream, or Services at the ANC site. You will provide floor support, drive readiness activities, and guide continuous improvement with a cross-functional team.

The role requires strong GMP documentation skills, change control experience, and collaboration with Process Development, Manufacturing Operations, and Supply Chain to optimize

Qualifications

• Doctorate degree and 2 years biotechnology operations experience OR
• Master’s degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years biotechnology operations experience OR
• Bachelor’s degree and 6 years biotechnology operations experience OR
• Associate’s degree and 10 years biotechnology operations experience OR
• High school diploma / GED and 12 years biotechnology operations experience

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 operations, changes, startups.
• Support readiness activities including water runs, dry runs, equipment readiness verification, and EBR testing support.
• Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.
• Monitor process performance and identify opportunities for optimization and risk reduction.
• Support manufacturing-related change controls, procedures, and CAPA activities.
• Author, revise, review, and maintain GMP documentation including SOPs and procedures.
• Ensure processes are translated into SOPs, workflows, training materials, and digital processes.
• Provide input to manufacturing risk assessments and assist investigations and CAPA effectiveness checks.
• Collaborate with Process Development for knowledge transfer and facility fit assessments.
• Coordinate with Supply Chain, Manufacturing, and Engineering on material readiness and BOM alignment.
• Support MES and EBR activities and participate in inspections and audits.

Skills

Upstream Manufacturing

Downstream Manufacturing

Manufacturing Services

GMP Documentation

Risk Assessments

Education

Doctorate degree

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

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

MES system

EBR system

SOPs & GMP docs

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, andhypercareduring 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 escalation 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

• Technicalexpertisein 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, andhypercareactivities.
• 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.
• Experienceparticipatingin 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.