MANUFACTURING SPECIALIST - Production Process Owner

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will act as a Production Process Owner (PPO) in a GMP Drug Product Fill Finish Facility.

The ATO Fill Finish facility is a dynamic environment and an important launch point for Amgens pipeline products. The Fill Finish Facility manufactures drug product for clinical trials through commercial production using single-use equipment platforms and stainless steel. The PPO will act as a technical liaison between the GMP manufacturing operations teams and subject matter experts across multiple functions such as supply chain, NPI, quality assurance, facilities and engineering, amongst others on a routine basis. This role ensures the success of day to day operations and leads process changes in support of continuous improvement.

Job scope and responsibilities:

• Own change controls and SOPs associated with the process(es) that you are assigned

• Support new technology initiatives by serving as the single point of contact and manager of technical knowledge of the technology advancements for manufacturing

• Engage with production staff to identify and execute grass roots continuous improvement efforts

• Provide on the floor support for new process implementation and troubleshooting

• Participate in internal/external audits

• Lead and own risk assessment activities

• Lead and own Continuous Improvement and Lean initiatives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Doctorate degree OR

Masters degree and 3 years of drug product operations experience OR

Bachelors degree and 5 years of drug product operations experience OR

Associates degree and 10 years of drug product operations experience OR

High school diploma / GED and 12 years of drug product operations experience

Preferred Qualifications:

• Bachelors or Masters in Chemical Engineering, Mechanical Engineering, or Biotechnology Engineering

• At least 10 years of biopharmaceutical experience within biopharmaceuticals manufacturing facility with preferred focus within aseptic and/or sterile filling environments.

• Technical knowledge of drug product operations

• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Ability to coach, mentor and/or cross train colleagues within core technical areas

• Background in lean manufacturing methodologies and operational excellence

• Experience in cross functional Project Management

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization

• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.

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.