Director Quality Control

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.

Director of Quality Control

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.

Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.

Lets do this. Lets change the world. By taking on this leadership role at this critical stage of facility build and start-up, you will have the opportunity to shape the future of Quality Control at Amgen North Carolina (ANC). This includes finalization of the laboratory design and systems, developing a site QC strategy that enables business imperatives, and building an organization of approximately 26 staff over the next several years.

Responsibilities:

Site construction, start-up, and operational readiness:

• Work directly with capital project team to confirm lab design, equipment, and systems.

• Accountable for ANC Laboratory Change Control.

• Develop and drive QC plan to support project stages including C&Q, EMC/EMPQ, methods transfer, and operational readiness.

• Make strategic decisions/recommendations on ANC capabilities, technologies, and insourcing/outsourcing support models.

• Build organization according to hiring strategy that supports project milestones. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs.

Ongoing operations:

• Responsible for compliant and efficient operation of ANC laboratory, including General Chemistry, Microbiology, BioAssay/ELISA, and Sample Management, as well as site EM and UM programs.

• Ensure accurate, reliable, robust analysis of EM, UM, in-process, release, and stability samples.

• Ensure laboratory equipment and systems are maintained according to Amgen standards.

• Monitor performance and drive continuous improvement throughout ANC QC operations.

Win

What we expect of you

Basic Qualifications:

Doctorate degree and 4 years of Quality/Quality Control experience

Or

Masters degree and 8 years of Quality/Quality Control experience

Or

Bachelors degree and 10 years of Quality/Quality Control experience

And

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

We are all different, yet we all use our unique contributions to serve patients. The Director of Quality Control we seek is a leader with these qualifications.

• Previous leadership experience in Quality Control Lab Operations.

• Expert knowledge of quality systems, analytical technologies, industry trends, and regulatory requirements.

• Strong ability to partner effectively with cross-functional colleagues and to leverage internal Amgen network.

• Strategic vision and continuous improvement mindset.

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.

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#AmgenNorthCarolina

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.

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.

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.