Specialist Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets change the world. In this vital role you will be working in Amgens new plant, AR30, responsible for drug substance manufacturing and release of Amgens 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

Masters degree and 3 years of Manufacturing and/or Operations experience or

Bachelors 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.