Senior Manufacturing Training Specialist

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen is building its most advanced FleXBatch drug substance plant and seeks a Manufacturing Training Specialist 5 to lead training strategy, qualification planning, and readiness governance across ANC-1 and ANC-2 startup activities. The role collaborates with Quality, Engineering, and Supply Chain to ensure ongoing startup and operational excellence.

The position emphasizes floor leadership, CAPA execution, and the rollout of the Wake Tech LMS migration, with a focus on manufacturing workforce

Qualifications

• PhD or equivalent with biotechnology ops experience.
• Advanced degree in chemistry, biology, or engineering preferred with hands-on training.
• Extensive experience in biotech operations and qualification planning.

Responsibilities

• Lead manufacturing training strategy and qualification pathways for ANC-1/ANC-2.
• Own and govern training-related CAPAs and continuous improvement initiatives.
• Coordinate with Quality, Engineering, Validation, and Supply Chain to align readiness milestones.
• Develop and deliver technical training programs, including LMS migrations.
• Coach teams on GMP, safety, and operational excellence.

Skills

Hands-on problem solving

GMP compliance

Cross-functional collaboration

Training delivery

Curriculum development

Education

Doctorate degree

Master's degree in chemistry/biology/engineering + 3 years biotech ops

Bachelor's degree + 5 years biotech ops

Associates + 10 years biotech ops

High school diploma + 12 years biotech ops

Tools

Learning Management Systems (LMS)

Job description

Amgen is building its most advanced FleXBatch drug substance plant and seeks a Manufacturing Training Specialist 5 to lead training strategy, qualification planning, and readiness governance across ANC-1 and ANC-2 startup activities. The role collaborates with Quality, Engineering, and Supply Chain to ensure ongoing startup and operational excellence.

The position emphasizes floor leadership, CAPA execution, and the rollout of the Wake Tech LMS migration, with a focus on manufacturing workforce