What are the responsibilities and job description for the Manufacturing CI Lead position at Amgen?
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Manufacturing CI Lead
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility.
During start up, Manufacturing Senior Associates will have ownership and oversight of operational readiness activities in manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing. Manufacturing Senior Associates will support Standard Operating Procedure (SOP) creation, review, and approval; specification and purchasing of required equipment and supplies, design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff. When the plant transitions to operations in 2025 this position will focus on providing technical and continuous improvement support.
- Provide technical support and subject matter expertise for manufacturing area.
- Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, Trackwise records, among others.
- Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
- Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility
- Facilitate process, area, and equipment risk assessments as needed to identify risks, failure modes, and mitigating actions
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.
Basic Qualifications:
- High school diploma / GED and 8 years of Manufacturing or Operations experience OR
- Associate’s degree and 6 years of Manufacturing or Operations experience OR
- Bachelor’s degree and 2 years of Manufacturing or Operations experience OR
- Master’s degree OR
Preferred Qualifications:
- Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
- Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
- Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff
- Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality
Thrive
What you can expect of us
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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 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 accommodation
