Specialist Stability – Amgen | On-Site | Hyderabad, India
Location: Hyderabad, India
Job Category: Quality
Work Type: On-Site
Experience Required: 10–12+ years (depending on qualification)
Job ID: R-230362
About the Role
Amgen is hiring a Specialist Stability to support its Product Quality Team (PQT), providing end-to-end ownership of stability programs for late-stage clinical and commercial products. This position plays a key role in maintaining product quality, regulatory compliance, and global documentation standards within GMP-compliant systems.
The role is based at the Amgen facility in Hyderabad, India and is ideal for professionals with strong experience in GMP stability programs, regulatory documentation, and scientific data management.
Key Responsibilities
Build, monitor, and manage product stability studies within GMP-compliant systems including LIMS, Veeva, and SampleManager.
Author and maintain GMP technical documents, stability protocols, and stability reports.
Generate and interpret stability data using electronic reporting tools such as Spotfire and SHINY.
Collate, verify, and archive GMP stability and product quality data in alignment with regulatory guidelines.
Coordinate global sample requests, study initiations, and cross-site quality activities.
Support internal and external GMP audits, ensuring documentation accuracy and inspection readiness.
Partner with global teams for Annual Product Reviews and regulatory submissions.
Contribute to process improvements, SOP development, and electronic data management enhancements.
Mentor and train team members to strengthen internal capabilities.
Qualifications & Experience
Basic Qualifications
Candidates must meet one of the following criteria:
Doctorate Degree in Life Sciences or Engineering
Master’s Degree with 10 years of experience in Quality, Operations, Scientific, or Manufacturing functions
Bachelor’s Degree with 12 years of experience in Quality, Operations, Scientific, or Manufacturing functions
Required Skills
In-depth understanding of GMP requirements, FDA guidelines, and ICH regulations.
Demonstrated experience managing the product stability lifecycle.
Strong scientific data management capabilities with high attention to detail.
Proven ability to author regulatory-quality documents.
Hands-on proficiency in GMP systems such as Veeva, LIMS, Spotfire.
Excellent communication and cross-functional collaboration skills.
Ability to manage time-sensitive activities independently in a fast-paced environment.
Continuous improvement mindset with experience in lean practices.
Proficiency in MS Office applications.
Preferred Skills
Experience in managing GMP stability programs in alignment with FDA and ICH standards.
Experience preparing and reviewing annual product reviews.
Expertise in digital quality systems (Veeva, Spotfire, SHINY).
Ability to collaborate effectively across global, matrixed teams.
Soft Skills
Strong analytical abilities and problem-solving approach.
Self-driven attitude with a commitment to delivering high-quality results.
Ability to manage multiple priorities under challenging timelines.
Effective presentation skills for audits, reviews, and cross-team meetings.
What Success Looks Like
Timely and accurate execution of stability studies and documentation.
Strong audit readiness backed by comprehensive, compliant records.
Effective coordination with global PQT teams to achieve shared objectives.
Positive contributions to team development through guidance and training.
Why Join Amgen
Amgen offers a collaborative and innovation-driven culture focused on advancing science to improve patient lives. Employees receive competitive compensation, development opportunities, and comprehensive benefits aligned with industry standards.
Apply Now
Begin your journey with a biotechnology leader committed to transforming patient care and scientific innovation.
Explore more opportunities at careers.amgen.com
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