Specialist - Manufacturing Investigations

Job Description

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? 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, reaching over 10 million patients worldwide.

Come do your best work alongside other innovative, driven professionals in this meaningful role.

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 disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate 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 be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

• Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, developing CAPAs, and documenting all findings in a compliant manner.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross‑functional teams through complex investigations, and complete milestones on schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem‑solving approach.
• Apply inductive and deductive reasoning in the investigation process.
• Produce clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
• Develop tracking tools to ensure on‑time closure and proactive review of deviation investigations.

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigation background with strong cross‑functional project management and communication skills as well as the following qualifications.

• Doctorate degree OR
• Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience OR
• Bachelor’s degree and 5 years of biotechnology operations experience OR
• Associate’s degree & 10 years of biotechnology operations experience OR
• High school diploma / GED & 12 years of biotechnology operations experience

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility.
• Experience with compliance, problem‑solving, simple and complex root cause analysis tools (5‑whys, fishbone, Kepner‑Tregoe Problem Analysis®, Design of Experiment, etc.) critical thinking, project management, and quality systems.
• Degree in Science or Engineering.
• Experience leading complex investigations.
• Experience using Veeva QMS for Deviation investigations and CAPAs.
• Demonstrated project management ability.
• Experience presenting to inspectors during regulatory inspections and internal audits.
• Exc…