Principal Product Quality Leader

Amgen • Thousand Oaks, CA

5d

About The Position

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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. 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. 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.

Requirements

• 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
• 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
• Strong scientific data management and organization skills with attention to detail
• Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed