CAREER CATEGORY

Quality

JOB DESCRIPTION

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 cutting-edge 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.

ABOUT THE ROLE

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:

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📌 Manager-Analytical & Data Verification (Hyderabad)
🏢 AMGEN
📍 Hyderabad