Senior Manufacturing Training Lead for Startup Readiness

Amgen Inc.; Holly Springs (NC); On-site; USD 108,000 - 146,000; Full time

Job summary

Amgen Inc. in North Carolina seeks a Manufacturing Training Specialist 5 to provide technical leadership and operational support for training across a 24/7 manufacturing site. You will ensure workforce readiness, qualification planning, and startup readiness while collaborating with Quality, Engineering, and HR teams.

The role requires strong program management, training development, and GMP compliance. You will drive CAPAs and continuous improvement, aligning with ANC-1 and ANC-2 readiness

Qualifications

• PhD or equivalent with biotechnology operations experience.
• Experience in training development and facilitation.
• Familiarity with LMS and training governance.

Responsibilities

• Develop and execute the manufacturing training strategy for ANC-1 and ANC-2.
• Create, implement, and mature the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2.
• Develop and maintain training governance tools, metrics, and reporting processes.
• Identify readiness risks and drive mitigations to protect milestones.
• Escalate and resolve issues threatening startup milestones or readiness.
• Strengthen alignment between hiring plans, qualification plans, and readiness milestones.
• Lead Manufacturing Fundamentals Training programs for onboarding and qualification.
• Lead LMS migration planning and adoption for 2027.
• Lead training improvement initiatives and CAPAs.
• Coach personnel on GMP and operational excellence.

Skills

Hands-on problem solving

Project management

Communication skills

Education

Doctorate degree

Master’s degree in chemistry, biology, or engineering

Bachelor’s degree in biotechnology operations

Associate’s degree

High school diploma / GED

Tools

Learning Management Systems (LMS)

Job description

Amgen Inc. in North Carolina seeks a Manufacturing Training Specialist 5 to provide technical leadership and operational support for training across a 24/7 manufacturing site. You will ensure workforce readiness, qualification planning, and startup readiness while collaborating with Quality, Engineering, and HR teams.

The role requires strong program management, training development, and GMP compliance. You will drive CAPAs and continuous improvement, aligning with ANC-1 and ANC-2 readiness