Lead Biotech Investigations Specialist (Remote)

Amgen; Holly Springs (NC); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision

Yearly bonus

Stock-based incentives

Paid time off

Flexible work options

Job summary

Amgen in North Carolina seeks a Senior Specialist – Complex Investigations to lead the most complex deviations and quality events at the Biologics Drug Substance Manufacturing site. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events and systemic issues.

This role requires scientific rigor, root-cause analysis, effective CAPAs, and clear communication to senior leadership, with

Qualifications

• PhD or MS with extensive investigations experience.
• Strong GMP knowledge and CAPA experience.
• Experience presenting to regulatory bodies.

Responsibilities

• Lead the site's most complex cross‑functional investigations.
• Serve as technical SME for quality, microbiology, and compliance issues.
• Mentor investigators and write executive investigation summaries.
• Present status, risks, and remediation plans to leadership.

Skills

Root cause analysis

Quality systems

Regulatory knowledge

Project management

Technical writing

Cross-functional collaboration

Education

Doctorate + 2 years

Master's + 4 years

Bachelor's + 6 years

Associate's + 10 years

High school + 12 years

Tools

Veeva QMS

Job description

Amgen in North Carolina seeks a Senior Specialist – Complex Investigations to lead the most complex deviations and quality events at the Biologics Drug Substance Manufacturing site. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events and systemic issues.

This role requires scientific rigor, root-cause analysis, effective CAPAs, and clear communication to senior leadership, with