Specialist Stability

What you will do

In this vital role you will be an individual contributor providing critical support to a Product Quality Team (PQT) by managing the stability program for late stage clinical and commercial products and providing data management support for additional aspects of the PQT and regulatory reporting.

The Specialist Stability builds and monitors product stability studies within compliant GMP quality systems (e.g., LIMS, Veeva), organizes and manages product quality and stability data, serves as a primary author on regulatory filing sections, and supports site-based GMP inspections. In addition, the Specialist Stability may provide business process improvements by authoring standard operating procedures (SOPs) or supporting the development of electronic data management tools (e.g., Spotfire applications). The role is based at the Amgen facility in Hyderabad, India.

Roles & Responsibilities

• Build, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)
• Author and maintain GMP technical documents and stability reports in compliant systems
• Provide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)
• Collate, review, verify, and archive GMP stability and product quality data
• Coordinate stability study starts and sample requests with global teams
• Participate in audits and inspections across multiple sites, ensuring readiness and compliance
• Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes
• Mentor and train staff, sharing expertise to strengthen team capabilities

What we expect of you

Basic Qualifications:

• Doctorate Degree in a Life Sciences or Engineering field OR
• Master's degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor's degree and 12 years of Quality, Operations, Scientific, or Manufacturing experience

Must-Have Skills:

• Thorough understanding of GMP requirements, US FDA, and ICH regulations
• Strong scientific data management and organizational skills with exceptional attention to detail
• Proven experience in managing the product stability life cycle
• Proven technical writing skills with ability to author regulatory-quality documents
• Ability to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)
• Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationships
• Proven ability to work independently and manage time-sensitive activities across teams
• Continuous improvement mindset with experience applying lean practices
• Proficiency in MS Office (Word, Excel, PowerPoint, Teams)

Good-to-Have Skills:

• Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulations
• Experience with authoring, assembling, and reviewing annual product reviews
• Expertise in GMP applications (Veeva, Spotfire, SHINY) and proficiency in MS Office (Word, Excel, PowerPoint, Teams)
• Experience collaborating across time zones in a global, matrixed team environment

Soft Skills:

• Strong analytical and problem-solving mindset
• Strong initiative and self-motivation to drive results under pressure
• Ability to work independently and balance multiple priorities while meeting challenging deadlines
• Team-oriented approach with a focus on achieving shared goals
• Strong presentation and public speaking skills for inspections and cross-team updates

What Success Looks Like

• Timely and accurate execution of stability studies and reports
• Readiness for audits and inspections with robust, compliant documentation
• Effective cross-functional collaboration to meet global PQT objectives
• Positive impact on team development through mentoring and training