Senior Associate Manufacturing - Product Lifecycle Management

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

The Senior Associate Manufacturing position is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions to the multi-facility site (AR5 and AR30) and managing the lifecycle of ARI's product portfolio.

Shift: Monday - Friday Admin Day Shift

Responsibilities:

• Create and maintain Electronic Batch Records.
• Drive continuous improvements of MBR System and PLM processes.
• Partner with manufacturing staff to develop and/or revise manufacturing SOPs to support new product introduction.
• Develop and maintain the Bill of Materials for each product manufactured at/ transferred to ARI.
• Support the development of manufacturing sample plans.
• Develop and maintain User Requirements (URS) for manufacturing equipment.
• Assist in developing and delivering training materials to manufacturing staff to support new product introduction, product reintroduction, etc.
• Own and manage change controls, NCs, and CAPAs.

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Manufacturing and Operations experience

OR

Associate's degree and 6 years of Manufacturing and Operations experience

OR

High school diploma / GED and 8 years of Manufacturing and Operations experience

Preferred Qualifications

• Manufacturing experience in both upstream and downstream operations.
• Strong understanding of manufacturing equipment and processes.
• Experience with SAP and MES.
• CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.
• Project Management Skills.
• Strong analytical and experimental design skills.
• Excellent verbal and written communication skills.
• Technical leadership experience.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.