Research Associate II – Stability SME
Location: Bengaluru, India
Job ID: JR - 179599
Job Type: Full-time
Department: Research and Development
Date Posted: July 24, 2025
Estimated Salary: ₹8.5 – ₹14 LPA (based on industry standards and experience level)
About Vantive:
Vantive is a leading global organization in vital organ therapy with a proud 70-year legacy in kidney care. As we continue to advance in the healthcare space, we’re investing in next-generation solutions, transforming dialysis experiences, and expanding our mission to vital organ therapies. If you’re driven by impact, growth, and meaning, Vantive offers a career that’s built for you.
Your Role:
As a Research Associate II – Stability Subject Matter Expert, you will support stability efforts for both new and existing drug products. You’ll lead critical stability planning activities that impact regulatory submissions, shelf-life justification, and global qualification of product changes. This is a high-impact position within the R&D Stability Team, requiring deep technical knowledge, strong data interpretation skills, and effective cross-functional collaboration.
Key Responsibilities:
Represent the R&D-Stability function on key project teams, providing strategic input to meet stability-related goals.
Develop and execute stability strategies to support product development and lifecycle management.
Establish and justify expiration dating for new and modified products through robust data analysis.
Collaborate with cross-functional teams (manufacturing, QA, regulatory) to ensure appropriate methods and specifications are in place for stability, compatibility, and release testing.
Author, review, and manage technical documentation, including protocols, reports, and regulatory submissions.
Use LIMS for study administration: building, reviewing, and updating data entries.
Investigate and document OOS/OOT (out-of-spec/out-of-trend) results with sound scientific rationale.
Contribute to continuous improvement initiatives and optimize existing processes within the Stability function.
Support the preparation of stability data packages for global regulatory filings.
Qualifications & Skills:
Education:
Bachelor’s degree with 8–12 years OR Master’s degree with 6–10 years in a scientific field (e.g., Chemistry, Pharmaceutical Sciences).
Technical Skills:
Strong foundation in analytical chemistry and stability testing principles.
Proficiency with scientific databases, LIMS, Excel, and technical writing.
Knowledge of FDA/ISO regulatory requirements and quality systems.
Familiarity with method validation, data trending, and ICH stability guidelines.
Soft Skills:
Strong problem-solving, analytical, and critical thinking abilities.
Effective written and verbal communication.
Ability to manage multiple tasks and meet deadlines across time zones.
Collaborative and inclusive team attitude with willingness to go beyond job scope when required.
Why Join Vantive?
Be part of a mission-driven company transforming vital organ therapy.
Work with cutting-edge teams on impactful R&D initiatives.
Thrive in a global, collaborative culture that values your ideas and growth.
Access opportunities for career development, innovation, and international exposure.
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