ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 whats known today.

ABOUT THE ROLE

Role Description:

This role is an individual contributor role that provides critical support to Product Quality Teams (PQTs) for late-stage clinical and commercial products. In this role, you will serve as a primary author of technical and regulatory reports, manage GMP data within compliant systems, and help ensure accuracy, completeness, and compliance across global submissions.

You will also play an integral role in maintaining Amgens electronic databases and mapping tools, supporting continuous improvement initiatives, and providing peer training as needed. This role requires strong expertise in GMP compliance,



technical writing, and cross-functional collaboration to drive high-quality outcomes under tight timelines.

Roles Responsibilities:
- Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva, Spotfire).
- Work closely with in the product Quality organization to drive standardization of data, and chromatographic overlay activities.
- Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva).
- Collate, review, verify, and archive GMP data for late-stage clinical and commercial products.
- Ensure accuracy and completeness of product data with high attention to detail.
- Collaborate across global teams and time zones, effectively communicating findings and project updates.

Basic Qualifications
- Masters degree with minimum 6 years of Pharmaceutical/Biotechnology experience in Quality, Operations, Scientific, or Manufacturing fields

Funct

📌 Sr Associate Product Quality (Hyderabad)
🏢 Amgen
📍 Hyderabad