Biotech Manufacturing Process Owner - Up/D/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

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.