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Research Associate Ii - Stability Sme

8-12 years
₹8.5 – ₹14 LPA
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.