Senior Specialist – Complex Investigations

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over ten million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single‑use technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company by 2027.

In this vital role, you will serve as the site expert responsible for leading the most critical, high‑risk, and complex investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events, recurring deviations, product‑impacting events, and systemic compliance issues.

This position is responsible for ensuring the site’s most consequential investigations are conducted with scientific rigor, thorough root‑cause determination, effective corrective and preventive actions, and clear communication to senior leadership. The role serves as the escalation point for investigations that present elevated product quality, patient safety, compliance, or regulatory risk.

• Lead the site’s most complex and cross‑functional deviation investigations.
• Serve as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues.
• Assemble and lead cross‑functional investigation teams through advanced root‑cause analysis and risk assessment activities.
• Apply advanced investigation methodologies including Kepner‑Tregoe, Quality Risk Management, 5‑Why, Fishbone Analysis, and data‑driven problem solving.
• Drive development of robust CAPAs and evaluate the effectiveness of implemented actions.
• Identify systemic opportunities and recurring trends across quality events and drive site‑wide improvement initiatives.
• Provide expert technical guidance and coaching to investigators and functional SMEs.
• Present investigation status, findings, risks, and recommendations to site leadership and governance teams.
• Support regulatory inspections and internal audits by presenting investigation strategies, outcomes, and associated remediation activities.
• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensure timely and compliant investigation closure.
• Develop and maintain metrics that assess investigation quality, effectiveness, and timeliness.
• Drive continuous improvement of investigation processes, tools, and standards across the site.
• Author and review technically complex investigation reports, risk assessments, and executive summaries.
• Mentor investigators on investigation excellence, technical writing, and root‑cause analysis.
• Influence site‑wide investigation practices through knowledge sharing, process optimization, and implementation of industry best practices.

What we expect of you

• Doctorate degree & 2 years of directly related experience
• Master's degree & 4 years of directly related experience
• Bachelor's degree & 6 years of directly related experience
• Associate's degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience

• 7+ years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.
• Extensive experience leading complex, cross‑functional investigations involving quality systems, manufacturing processes, microbiology, contamination…