Specialist Quality Control Support - Stability

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

Specialist Quality Control Support - Stability

What you will do

Let’s do this. Let’s change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Specialist QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Under minimal supervision, the successful candidate will support the startup of the QC organization by:

• Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy
• Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs
• Manage Stability Requests with Global Stability Coordinators and Product Quality Leads
• Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies
• Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol
• Ensure stability studies are initiated within protocol timelines
• Work collaboratively with site teams
• Ensure stability program is adherent to all cGMP regulations
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Control experience OR
• Associate’s degree and 8 years of Quality Control experience OR
• Bachelor’s degree and 4 years of Quality Control experience OR
• Master’s degree and 2 years of Quality Control experience OR
• Doctorate degree

Preferred Qualifications:

• Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
• 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Strong knowledge of aseptic technique.
• Proficient in the use of LIMS & LMES/CIMS.
• Experience in a lead role, providing guidance to team members.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Familiar with authoring or owning change control records.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.