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Job description
Join Amgen's mission to serve patients by providing technical expertise and product leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
Provide technical expertise and project support to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Product Development Team goals. This includes ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems, and product data management.
We are looking for a collaborative partner with a Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or equivalent. The ideal candidate will have experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, and a strong foundation in chemistry.
Company
Healthcare
Amgen is a global biotechnology leader that develops biologic and human therapeutics to treat serious diseases such as cancer, heart disease, osteoporosis, inflammatory disorders, and rare conditions. Leveraging advanced genetic data and cutting-edge technology, the company maintains a robust R&D pipeline that expands its existing portfolio of life-changing medicines. Amgen’s commitment to innovation is reflected in its status as a Dow Jones Industrial Average constituent, a Nasdaq 100 member, and a Fast Company World's Most Innovative Companies honoree. The firm is recognized for its strong employee culture, earning a spot on Forbes’ list of America’s Best Large Employers. Amgen’s pioneering approach to drug discovery and development continues to set industry standards and improve patient outcomes worldwide.
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