Specialist – Stability
Location: India, Hyderabad
Work Type: On-Site
Job ID: R-230362
Date Posted: November 13, 2025
Category: Quality
About the Company
Amgen is a global biotechnology leader committed to advancing science and delivering breakthrough therapies for patients living with serious illnesses. Since 1980, the organization has pioneered innovative solutions across Oncology, Inflammation, General Medicine, and Rare Disease, reaching millions of patients each year. With a collaborative, science-driven culture, Amgen empowers professionals to make meaningful contributions while growing their careers.
Role Overview
The Specialist – Stability is a critical individual contributor role within the Product Quality Team (PQT). The position is responsible for managing stability programs for late-stage clinical and commercial products, overseeing stability studies, managing GMP data, and supporting regulatory filings. This role operates within compliant GMP systems and plays a key role during audits and inspections.
The position is based at the Amgen Hyderabad facility and involves collaboration with global teams, authorship of stability documentation, and continuous improvement initiatives.
Key Responsibilities
Stability Management & GMP Operations
Build, manage, and monitor product stability studies using compliant GMP systems (e.g., Veeva, LIMS, SampleManager).
Author, review, and maintain GMP technical documentation and stability reports.
Compile, verify, review, and archive product quality and stability data.
Data Management & Reporting
Generate stability data reports using electronic tools such as Spotfire and SHINY.
Organize and manage stability and quality datasets to ensure accuracy and compliance.
Cross-Functional Coordination
Coordinate stability study start-ups and sample requests with global teams.
Collaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor Changes.
Compliance, Audits & Inspections
Participate in site audits and inspections to ensure regulatory readiness.
Maintain high-quality documentation supporting GMP compliance.
Training & Continuous Improvement
Mentor and train staff to enhance team capability.
Contribute to process improvements through SOP development and automation initiatives.
Qualifications
Basic Qualifications (Must Meet One)
Doctorate in Life Sciences or Engineering
OR
Master’s degree with 10 years of experience in Quality, Operations, Scientific, or Manufacturing roles
OR
Bachelor’s degree with 12 years of experience in Quality, Operations, Scientific, or Manufacturing roles
Required Skills (Must-Have)
Strong understanding of GMP, US FDA, and ICH guidelines
Proven experience managing product stability life cycles
Demonstrated ability to author regulatory-standard technical documents
Experience working with GMP systems such as Veeva, LIMS, SampleManager, and Spotfire
Strong scientific data management capabilities with exceptional accuracy
Excellent verbal and written communication skills
Ability to manage time-sensitive tasks independently
Proficient in MS Office (Word, Excel, PowerPoint, Teams)
Continuous improvement mindset with exposure to lean practices
Preferred Qualifications (Good-to-Have)
Prior experience managing GMP stability programs for pharmaceutical products
Experience authoring and reviewing Annual Product Reviews
Expertise with advanced GMP applications (Spotfire, SHINY, Veeva)
Experience collaborating in global, matrixed environments
Ability to work effectively across time zones
Soft Skills
Strong analytical and problem-solving abilities
Self-motivated with a strong sense of ownership
Ability to prioritize multiple high-impact tasks
Effective team collaborator
Strong presentation and stakeholder communication skills
Success Indicators
High-quality, timely execution of stability studies and reporting
Full audit and inspection readiness
Strong cross-functional collaboration to support PQT goals
Positive contribution to team development and training initiatives
What You Can Expect
Amgen offers a competitive Total Rewards Program aligned with industry standards. Employees benefit from:
Professional development opportunities
A collaborative and inclusive work culture
Comprehensive employee support for personal and professional well-being
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without discrimination. Reasonable accommodations are available for applicants with disabilities participating in any stage of the hiring process.
How to Apply
Submit your application via the official Amgen Careers portal.
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