Synthetics Principal Product Quality Leader

Amgen is recruiting for a Synthetics Principal Product Quality Leader to provide technical expertise and product leadership in product quality across manufacturing, regulatory, and development. The role will work with Product Quality Leads and cross‑functional teams to ensure product specifications, controls, and regulatory submissions meet cGMP and international standards. Key Responsibilities Provide cross‑functional quality leadership and support PDT deliverables for late phase and commercial synthetic programs, including PQT, APR, specification, comparability, and stability programs. Support science and risk‑based evaluation of complex process and product quality data, developing patient‑oriented strategies that align with business needs. Communicate complex information orally and in writing to Product Quality leadership, peers, and regulatory agencies. Demonstrate proficiency in cGMP and international regulatory expectations. 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 & 10 years of Quality, Operations, Scientific, or Manufacturing experience OR High School Diploma/GED & 12 years of Quality, Operations, Scientific, or Manufacturing experience. Preferred Qualifications B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment. 6+ years working in a regulated environment (direct GMP or technical support). 1+ year experience with authoring or reviewing market applications, INDs, supplements or similar regulatory documentation. 1+ year experience supporting non‑conformance investigations and authoring, reviewing, and defending critical product‑impacting non‑conformances. Experience in project management supporting 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 pertinent to pharma and biopharma. Experience working on a cross‑functional team in a matrix environment. Excellent written and verbal communication skills, including facilitation and presentation skills. Strong foundation in chemistry and experience with new synthetic modalities/technologies such as peptides, siRNA, new extended‑release formulations, and/or combination products. Benefits Overview Amgen offers a competitive Total Rewards Plan that includes health, welfare, and retirement benefits; discretionary bonuses; stock‑based incentives; generous paid time‑off; and flexible work models. Equal Opportunity Employer 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. #J-18808-Ljbffr Amgen