Specialist Manufacturing Process Owner - Upstream / Downstream / Services

Live What You Will Do

In this vital role, you will serve as a Process Owner within the Manufacturing Support organization at Amgen North Carolina (ANC).

• Support manufacturing execution through technical process ownership, floor support, operational readiness activities, process governance, manufacturing change implementation support, and continuous improvement initiatives.
• 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, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first-time executions.
• 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 escalate process, operational, quality, and compliance concerns.

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

• Techical 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.
• Knowledge of single-use technologies and Bill of Material (BOM) structures.
• Strong technical writing, communication, problem-solving, and organizational skills.