Biotech Manufacturing Training Lead

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

Job summary

Amgen North Carolina is seeking a Manufacturing Training Specialist – Manufacturing Support to drive workforce readiness for ANC-1 and ANC-2 startups. You will lead training strategy, qualification planning, and CAPA management to ensure safe, compliant operations.

Collaborating with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing, you will deliver training governance, LMS initiatives, and hands-on coaching for frontline teams in a 24/7 facility.

Qualifications

• Doctorate or Master’s in chemistry, biology, or engineering with biotech ops experience.
• Bachelor’s in biotech ops with 5+ years experience.
• Associate’s with 10+ years or HS with 12+ years of biotech ops experience.

Responsibilities

• Develop and execute the manufacturing training strategy for ANC-1 and ANC-2.
• Lead qualification planning and execution to support readiness milestones.
• Establish governance tools, metrics, and reporting processes for training compliance.
• Coach personnel on GMP compliance and operational excellence.
• Collaborate with Quality, Engineering, Validation, and HR on readiness governance.
• Own CAPAs related to training and qualification.

Skills

GMP compliance

Training development

Training facilitation

SOP editing

Deviation management

Project management

Communication skills

Relationship building

LMS knowledge

Education

Doctorate degree

Master’s degree in chemistry/biology/engineering

Bachelor’s degree in biotechnology operations

Associate’s degree + 10 years biotech ops

HS diploma + 12 years biotech ops

Job description

Amgen North Carolina is seeking a Manufacturing Training Specialist – Manufacturing Support to drive workforce readiness for ANC-1 and ANC-2 startups. You will lead training strategy, qualification planning, and CAPA management to ensure safe, compliant operations.

Collaborating with Quality, Engineering, Validation, Supply Chain, HR, and Manufacturing, you will deliver training governance, LMS initiatives, and hands-on coaching for frontline teams in a 24/7 facility.