Senior Manufacturing Training Lead – Startup Readiness

Amgen; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen in North Carolina seeks a Manufacturing Training Specialist 5 to lead training strategy across ANC-1 and ANC-2, focusing on workforce readiness, qualification planning, and startup readiness milestones. You will coordinate with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing to ensure compliant, effective programs.

The role requires advanced degrees with biotech operations experience or extensive equivalent; you will own CAPAs, develop TAPs, and guide LMS migration

Qualifications

• Doctorate or master’s with biotech operations experience or Bachelor’s with 5 years biotech ops.
• Experience with training development and facilitation.
• Experience owning and editing SOPs.
• Strong communication and relationship-building.

Responsibilities

• Develop and execute the manufacturing training strategy for ANC-1 and ANC-2.
• Lead Training Assignment Portfolio (TAP) and qualification pathways.
• Maintain governance tools, metrics, and reporting for training compliance.
• Identify readiness risks and drive mitigation actions.
• Coach personnel on GMP, training best practices, and readiness.
• Partner with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing.

Skills

Training development

Facilitation

LMS

Project management

Communication skills

Education

Doctorate degree

Master’s degree in chemistry, biology, or engineering

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

LMS

SOP editing

Deviation management systems

Project management tools

Job description

Amgen in North Carolina seeks a Manufacturing Training Specialist 5 to lead training strategy across ANC-1 and ANC-2, focusing on workforce readiness, qualification planning, and startup readiness milestones. You will coordinate with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing to ensure compliant, effective programs.

The role requires advanced degrees with biotech operations experience or extensive equivalent; you will own CAPAs, develop TAPs, and guide LMS migration