Principal Product Quality Leader

The Principal Product Quality Leader provides 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.

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

This role will support one or more of Amgen's products. The individual will 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. The PQL will be directly responsible for Product Quality related tasks including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (change control, data systems, etc), and product data management, including comparability assessments, annual product reviews, and product quality risk assessments. In addition, the PQL will play a role in supporting Product Quality initiatives intended to ensure the overall product health.

Responsibilities:

• Provide cross-functional quality leadership, and support PDT deliverables for late phase and commercial 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
• Communicate complex information to Product Quality leadership, peers and regulatory agencies

Basic Qualifications

Doctorate degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience

OR

Master's degree and 6 years of Quality, Operations, Scientific, or Manufacturing experience

OR

Bachelor's degree and 8 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 biologic and 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.

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