HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Associate Manufacturing- Process Owner

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in one the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations. Amgen’s new plant, AR30, is responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative single use manufacturing platforms and technologies. We are looking for a talented Senior Associate Manufacturing to joining the manufacturing technical support function, initially to help with startup operations for our Next Generation Bio-manufacturing plant.

This individual contributor position reports into the Downstream Manager of the AR30 Manufacturing Support Team and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects.

The focus of this role will be collaboration with the AR30 team to support the facility for commercial operations. This includes and is not limited to supporting manufacturing operations team, SOPs, major deviations, raw materials deviations, CAPAs, EVs, change controls, electronic batch records, job hazards analysis, improvement projects and standard work and, improvement projects, and participating in NPIs and PRIs.

Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing area. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations. Senior Associate Manufacturing may participate in cross-functional teams and represent the Purification groups. Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Unit operations, SOPs, CAPA’s, Change controls and Deviations. In addition, Senior Associate Manufacturing will identify, recommend, and implement improvements related to routine floor operations in solution preparation, cell culture and purification.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a collaborative partner with these qualifications.

Basic Qualifications

• Masters Degree OR
• Bachelor's degree with 2 years of manufacturing experience Or
• Associate degree and 6 years of Manufacturing or Operations experience Or
• High School diploma/GED and 8 years of Manufacturing or Operations experience.

Preferred Qualifications:

• Single use technology experience
• Cell Culture Experience and/or Purification experience
• Regulatory knowledge and experience with regulatory audits
• Ability to interpret and apply GMP knowledge
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
• Mechanical expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical and mathematical skills
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Manufacturing equipment including single use equipment
• Experience with Delta V/MES

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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