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Biologics Principal Product Quality Leader-US Remote

Employer
Amgen
Location
Thousand Oaks, CA
Start date
May 24, 2022

Job Details

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.

Biologics Principal Product Quality Leader

Live

What you will do

Lets do this. Lets change the world. In this vital role you will will provide technical expertise and project leadership to the Product Quality organization. As a product specialist in Quality, the Principal Product Quality Leader (referred to as a Product Quality Principal / PQP) has responsibility for working with PQLs, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments on the resolution of issues associated with process/manufacturing, in-process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections.

This role will support one or more of Amgen's products. The individual will provide technical expertise and project leadership to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the GOT and product goals for Amgen products. The individual will be directly responsible for Product Quality related tasks in support of the Product Quality Teams, including ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, etc.). In addition to these responsibilities, the candidate will be expected to play a role in supporting product quality issues and initiatives intended to ensure the overall product health.

Win

What we expect of you

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

Basic Qualifications:

  • Doctorate degree & 2 years of Quality experience Or
  • Masters degree & 6 years of Quality experience Or
  • Bachelors degree & 8 years of Quality experience or
  • Associate's degree & 10 years of Quality experience or
  • High school diploma/GED & 12 years of Quality experience

Preferred Qualifications:

  • B.S. in biochemistry, biology, or a related protein sciences/biotechnology field and 8+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, OR an Advanced degree in biochemistry, biology, or a related protein sciences/biotechnology field and 4+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
  • 6+ years working in a regulated environment (either direct GMP or technical support)
  • 1+ year experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation
  • 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
  • Experience in Project Management in support of biopharmaceutical development
  • Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies
  • Experience in direct interaction with regulatory agencies during inspections and/or meetings
  • Knowledge of analytical techniques used for biologics product quality control
  • Understanding of biopharmaceutical bulk and drug product development and manufacturing
  • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals
  • Experience working on a cross-functional team in a matrix environment
  • Excellent written and verbal communication skills, including facilitation and presentation skills

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.

  • 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.

careers.amgen.com

#LI-Remote


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, Puerto Rico and Canada 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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