Research Scientist I – Extractables & Leachables (E&L) | Vantive | Bengaluru, Karnataka
Req #: JR-174082
Employment Type: Full-time
Department: Research and Development
Posted On: 09/06/2025
About Vantive:
Vantive is a global leader in vital organ therapy with 70 years of groundbreaking innovation in kidney care. With a mission to extend lives and improve patient outcomes, Vantive is committed to transforming dialysis and expanding the horizon of vital organ treatments through digital and clinical advancements. If you’re passionate about solving real-world health challenges through science, Vantive is the right place for you.
Position Summary:
As a Research Scientist I – E&L, you’ll be a key contributor in Vantive’s materials, chemical characterization, and trace analysis team. You’ll use your advanced expertise in extractables & leachables (E&L), nitrosamines, and mass spectrometry to assess product safety and regulatory compliance. This high-impact role supports critical change control activities across Vantive’s global Renal and Acute Care portfolios.
Key Responsibilities:
Develop risk-based, scientifically sound strategies for trace analysis in medical devices and combination products.
Lead and support E&L and nitrosamine studies for regulatory submissions and ongoing compliance.
Conduct impact/gap assessments for product changes, collaborating with stakeholders across regulatory, toxicology, design, and quality teams.
Author and review technical documents such as study protocols, impact assessments, and regulatory reports.
Design and oversee laboratory studies (in-house and CROs) using advanced analytical tools like LC-MS, GC-MS, and other trace-level techniques.
Serve as a study director for multiple parallel projects, managing resources and deadlines.
Ensure compliance with QMS and global regulatory expectations (e.g., FDA, ISO 10993).
Participate in scientific forums and stay updated on evolving regulatory and analytical trends.
Candidate Profile:
Education: Postgraduate or PhD in Pharmaceutical Sciences, Analytical Chemistry, or Organic Chemistry (M. Pharm, M.Sc., Ph.D.).
Experience: Minimum 10 years of relevant experience in E&L or trace analysis within R&D or regulated environments.
Skills Required:
Hands-on expertise in LC-MS, GC-MS, and nitrosamine detection.
Deep understanding of GMP and change control processes.
Strong knowledge of global regulatory expectations for E&L in drugs and devices.
Effective communication, strategic thinking, and problem-solving abilities.
Proven experience working in global cross-functional teams.
Ability to manage multiple projects, write technical justifications, and mentor junior scientists.
Salary: ₹18 LPA – ₹25 LPA (estimated based on senior research roles in chemical characterization within the Indian medical device and pharma industry)
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