Specialist Manufacturing Investigations

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. 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 10 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 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.

Specialist-Manufacturing Investigations Live What you will do Let’s do this. Let’s change the world. In this vital role, you will be a key member of the team that investigates major d eviations 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 S, and Quality . This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include: Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. 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 Clear and concise technical writing Use O perational L earning T eam strategies to promote open collaboration with staff to maximiz e investigation findings . Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

Win What we expect of you 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 s background with strong cross-functional project management and communication skills as well as the below qualifications