Manager-Analytical & Data Verification

Career Category

Quality

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Role Description:

The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgen’s products. In this team-based role, Manager Stability will collaborate with Product Quality Teams (PQTs), supporting specialist teams, and Global stability teams to ensure the design, management, maintenance, and data analysis of a product’s stability program support GMP compliance and meet the Market Authorization commitments. In this management role you will provide critical support to PQTs through management of activities and staff supporting different programs for late-stage clinical and commercial products.

In this team-oriented manager role, you will serve as a subject matter expert of GMP data management strategy, directly adding to the success of PQTs by ensuring support for the product Quality strategies. In this role, you will be working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities. Such activities include managing data standardization activities, Chromatographic overlays, data verification and, where warranted, investigations, regulatory submissions and support for inspections across the Amgen manufacturing and testing network.

Roles & Responsibilities:

• Directly supervise Quality staff supporting Product Quality Teams and activities enabling regulatory submissions

• Adeptly manage staff training and independently coordinate staff assignments supporting time-sensitive activities across multiple teams