Senior Associate Manufacturing – Manufacturing Investigations

About this role

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.  

Senior 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   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   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   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.   

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

Basic Qualifications :  

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience  

Or​  • Associate’s Degree + 2 years manufacturing and/or other regulated environment experience  

Or​  • Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience  

Or  • Master's ​Degree 

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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Apply now  

for a career that defies imagin

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