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.

Lead Associate Manufacturing – 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 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, EHSS, 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 simple deviation and environmental monitoring investigations, specifically within the Controlled Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.

• Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.

• Interpret environmental monitoring data, identify trends, and assess potential impacts to product quality, manufacturing operations, and contamination control programs.

• 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 investigations, and complete milestones on-schedule.

• Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner. 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 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.

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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 microbiological investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

Bachelor’s degree or & 6 months of directly related experience

Or

Associate’s degree & 2 years of directly related experience

Or

High school diploma / GED & 4 years of directly related experience

Preferred Qualifications:

• 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility

• Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.

• Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone etc.) critical thinking, project management, and quality systems.

• Degree in Science or Engineering (Microbiology or similar a plus)

• Experience leading investigations

• Experience using Veeva QMS for Deviation investigations and CAPAs

• Demonstrated project management ability

• Excellent written and verbal communication skills

• Ability to work in a team matrix environment and build relationships with partners

• Strong interpersonal skills

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Thrive

What you can expect of us

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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