Senior Manufacturing Training Lead for Startup Readiness

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

Job summary

Amgen in Holly Springs, NC is seeking a Manufacturing Training Specialist 5 to lead training programs for ANC-1 and ANC-2 startups and ongoing operations. You will own qualification planning, TAP development, and LMS governance while coordinating with Manufacturing, Quality, Engineering, and Continuous Improvement teams to ensure readiness and strong GMP compliance.

The role emphasizes floor presence, cross‑functional leadership, and data‑driven decisions to sustain startup readiness and

Qualifications

• Doctorate or Master’s in a relevant science or engineering field with biotech operations experience.
• Experience in training development, facilitation, and SOP management.
• Strong knowledge of GMP, training governance, and LMS systems.

Responsibilities

• Develop and execute training strategy for ANC-1 and ANC-2 startups and ongoing manufacturing operations.
• Own qualification planning, TAP development, and readiness governance.
• Lead LMS-related migrations and cross-functional training initiatives.
• Coach frontline leaders on GMP and operational excellence, and drive CAPAs to closure.
• Partner with QA, Eng, Validation, Supply Chain, HR and Manufacturing for readiness milestones.

Skills

LMS knowledge

GMP compliance

Training development

Facilitation

Problem solving

Cross-functional collaboration

Project management

Data-driven decision making

Communication skills

Education

Doctorate degree

Master’s degree in chemistry, biology, or engineering

Bachelor’s degree + 5 years biotech ops

Associate’s degree + 10 years biotech ops

High school diploma + 12 years biotech ops

Tools

LMS

SOP editing

Job description

Amgen in Holly Springs, NC is seeking a Manufacturing Training Specialist 5 to lead training programs for ANC-1 and ANC-2 startups and ongoing operations. You will own qualification planning, TAP development, and LMS governance while coordinating with Manufacturing, Quality, Engineering, and Continuous Improvement teams to ensure readiness and strong GMP compliance.

The role emphasizes floor presence, cross‑functional leadership, and data‑driven decisions to sustain startup readiness and