Principal Product Quality Leader

Career Category

Quality

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Principal Product Quality Leader

What you will do

Let’s do this. Let’s change the world. Amgen’s corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

You will support one or more of Amgen's late-stage or commercial biologics products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities include the following:

• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author 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
• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

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 advanced 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) with experience working with biologic products
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation

Functional Skills:

Must-Have Skills:

• 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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