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Synthetics Principal Product Quality Leader

United States of America, Thousand Oaks Employment contract 138639.25 - 187570.75 USD / Year · Job Posted June 09, 2026
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Job Description

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Job Responsibility

  • Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs
  • site and method transfers
  • product quality impact statements for NCs
  • and PQ owned regulatory filing sections and RTQs
  • Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
  • Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
  • Demonstrate proficiency in knowledge of cGMP and international regulatory expectations

Requirements

  • Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience
  • Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience
  • Bachelor’s degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience
  • Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience
  • High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience

Nice to have

  • B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
  • 6+ years working in a regulated environment
  • 1+ year experience with authoring or review of market 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 pharmaceutical development
  • Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
  • General knowledge of cGMP and US & international filing regulations, practices, and trends
  • Experience working on a cross-functional team in a matrix environment
  • Excellent written and verbal communication skills
  • A strong foundation in chemistry and experience with new synthetic modalities/technologies such as peptides, siRNA, new extended release formulations, and or combination products

What we offer

  • comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models

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