Synthetics Principal Product Quality Leader

Synthetics Principal Product Quality Leader Amgen is looking for a senior quality professional to lead product quality initiatives for our synthetic product portfolio, ensuring compliance with cGMP, regulatory requirements, and scientific excellence. What you will do Provide technical expertise and product leadership to the Product Quality organization. You will collaborate with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance, and other departments on projects, issue resolution, and investigations related to manufacturing, in‑process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions, and inspections. Key Responsibilities Provide effective, cross‑functional quality leadership and support PDT deliverables for late‑phase and commercial synthetic programs. Support science and risk‑based evaluation of complex process and product quality data, developing patient‑oriented strategies and 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. Basic Qualifications Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience, OR Master’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience, OR Bachelor’s degree and 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 advanced degree in chemistry, biochemistry, biology, or related pharmaceutical sciences with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing. 6+ years in a regulated environment (direct GMP or technical support). 1+ year experience authoring or reviewing 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 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. 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, or combination products. Benefits Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental, vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for sales representatives, a sales‑based incentive plan. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Salary Range

138,639.25 USD – 187,570.75 USD

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 Dormont Manufacturing Co