Senior Quality Engineer

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.

What you will do

Let’s do this. Let’s change the world. In this vital role you be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.

Responsibilities:

• Provides quality oversight of the development, maintenance, transfer and

• validation of physical methods including sample selection

• Provides Quality guidance to CPO activities and results

• Quality approval of protocols and technical reports for method development

• Provides advice to inform Quality Plan

• Provides advice and expertise to inform development of technical training materials for method transfer

• Oversight of protocols and requirements to outsource testing to labs

• Review/Approve method development, validation, and transfer reports

• Review of change controls, CAPAs, and NCs

• Successful CPO method stewardship work

• Development of Method training materials

• Closely works under the guidance from CPOQ Core leadership in US.

• Collaborate with and/or provide advice to Regulatory to inform submissions

• Align with Attribute Sciences where similar networks or governances are established

• Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or supplier

• NOTE: This role may require working in shifts or extended hours within the same shift

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 8 to 12 years of Quality experience OR

• Bachelor’s degree and 10 to 13 years of Quality experience OR

Preferred Qualifications:

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)

• Bachelor’s Degree in a Science Field

• Ability to oversee multiple medium complexity projects simultaneously

• Working knowledge of quality engineering and/or mechanical engineering

• Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)

• Prior experience working as part of a combination product launch team

• Able to successfully manage workload to meet timelines

• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Experience driving decision making by using Decision, Advice and Inform (DAI) principles

• Understanding of industry requirements/expectations of a Quality Management System (QMS)

• Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations

• Comfortable with both drug and device terminology

• Ability to travel +/- 15-20% of time to domestic and international Amgen sites

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.

careers.amgen.com

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.