Manufacturing Process Owner - Upstream/Downstream Expert

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

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