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.

Specialist Manufacturing

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be working in Amgen’s new plant, AR30, responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative single use manufacturing platforms and technologies. This individual contributor position reports into the Senior Manager of the Product Life Cycle Management Group and interacts broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects. This individual will be joining the manufacturing technical support function, initially to help with startup operations for our new single use drug substance manufacturing plant.

• Provide data to support management evaluation of performance trends
• Provide subject matter expertise for area of responsibility/ownership
• Own quality records (change control, CAPA, deviations) and deliver to timelines
• Identify and autonomously implement continuous improvement opportunities
• Creation of solid business cases for improvement ideas
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement Buffer/Media Preparation, Cell Culture and/or Purification and drug substance filling processes and process improvements
• Support of front line managers through on the floor presence
• Own and author critical standard operating procedures and supporting documentation/training.
• Review and approval of master batch records
• Lead and/or support root cause investigations related to performance trends and formal deviations
• Support of new product and product reintroductions
• Develop, implement and assess solutions for complex problems
• Anticipate risk and builds contingencies to help mitigate impact
• Participate in regulatory audits

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a talented individual with these qualifications.

Basic Qualifications:

Doctorate degree or

Master’s degree and 3 years of Manufacturing and/or Operations experience or

Bachelor’s degree and 5 years of Manufacturing and/or Operations experience or

Associate degree and 10 years of Manufacturing and/or Operations experience

Preferred Qualifications

• Excellent Technical Writing skills
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment - Develops, implements and assesses solutions for complex problems
• Own and author critical standard operating procedures and supporting documentation/training.
• Ability to recommend, judge, and make good decisions in complex situations, Single use technology experience
• Ability to tactfully and effectively negotiate and influence
• Ensure effective decision-making
• Responsible for overseeing new technology and new product introduction in manufacturing
• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement Buffer/Media Preparation, Cell Culture and/or Purification and drug substance filling processes and process improvements
• Extensive experience defending approaches during regulatory audits
• Cell Culture Experience
• Purification experience
• Strong project management skills with ability to multi-task and function in a dynamic environment
• Excellent communication skills, drive, and sense of urgency
• Demonstrated ability to forge and maintain strong relationships within other functional areas
• Lead and/or support root cause investigations related to performance trends and formal deviations
• Support of product reintroductions
• Anticipate risk and builds contingencies to help mitigate impact
• Participate in regulatory audits

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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.

careers.amgen.com