Principal Product Quality Leader (Synthetics)

About the Position

Principal Product Quality Leader (Synthetics)

US - California - Thousand Oaks

JOB ID: R-257702

LOCATION: US - California - Thousand Oaks ; US - Massachusetts - Cambridge

WORK LOCATION TYPE: Flex Commuter / Hybrid

DATE POSTED: Oct. 13, 2026

CATEGORY: Quality

SALARY RANGE: 138,639.25 USD - 187,570.75 USD

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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. 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.

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Responsibilities

• 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

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Requirements

Basic Qualifications:

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

Preferred Qualifications:

• B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• 6+ years working in a regulated environment (either direct GMP or technical support)
• 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 pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
• Experience working on a cross-functional team in a matrix environment
• Excellent written and verbal communication skills, including facilitation and presentation 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 is a plus

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We Offer

• A 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
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

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About the Company

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.

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

careers.amgen.com