Synthetics Principal Product Quality Leader

Synthetics Principal Product Quality Leader

Let’s do this. Let’s change the world. In this vital role you will provide 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 synthetic 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 individual 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 candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. This role is preferred to be on site at one of Amgen locations, remote will be considered if applicable.

• Provide effective, cross‑functional quality leadership, and support PDT deliverables for late phase and commercial synthetic 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
• 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

• Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience
• Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience
• Bachelor’s degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience
• Associate’s degree and 10 years of Quality, Operations, Scientific or Manufacturing experience
• High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience

• 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)
• 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 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…