Research Associate II – Preclinical (Toxicology & Biocompatibility)
Location: Bengaluru, India
Job ID: JR - 178340
Job Type: Full-time
Department: Research and Development
Date Posted: July 10, 2025
Estimated Salary: ₹10 – ₹18 LPA (based on qualifications and experience)
About Vantive:
Vantive is a global innovator in vital organ therapy, with a 70-year legacy in delivering advanced care across dialysis and organ support. We’re expanding our impact by investing in digital solutions and smarter drug-device combinations. At Vantive, your expertise contributes directly to improving patients' lives.
Role Overview:
As a Research Associate II – Preclinical, you will apply your expertise in toxicology and biocompatibility to design and execute safety evaluations of drugs, drug-device combinations, and medical devices. You'll support preclinical development through risk assessments, regulatory documentation, and technical leadership in compliance with ISO 10993 and ICH guidelines.
Key Responsibilities:
Study Design & Monitoring:
Independently or collaboratively plan, monitor, and document GLP-compliant toxicity and biocompatibility studies.
Contribute to qualification of extractables, leachables, residual solvents, and excipients.
Author toxicological risk assessments and regulatory documentation (e.g., PBRER, eCTD).
Toxicological Assessment:
Conduct hazard evaluations of chemicals and author Safety Data Sheets (SDS).
Utilize in silico tools to predict toxicological endpoints.
Interpret toxicology results, draw conclusions, and prepare reports for regulatory submissions.
Regulatory & Technical Collaboration:
Act as SME for preclinical/toxicology functions in technical team meetings.
Participate in impact assessments and change control processes.
Ensure adherence to OECD, GLP, ICH Q3, ISO 10993-17, and FDA toxicology standards.
Required Qualifications:
Education:
Master’s degree in Life Sciences, Pharmacy, Biotechnology, or Veterinary Sciences with 4–6 years of experience
OR Ph.D. with relevant thesis/Post-doc in in vitro/in vivo toxicology, sterile injectable R&D, or medical device testing
Technical Skills:
Proficiency in toxicological study design, GLP compliance, ISO 10993-17, ICH Q3
Familiarity with in silico tools and risk assessment methods
Strong documentation and data interpretation abilities
Soft Skills:
Clear, concise communication in English (written & verbal)
Ability to independently manage multiple priorities
Proven stakeholder collaboration in a matrixed global environment
Why Vantive?
Engage in meaningful work that supports global regulatory submissions and patient safety
Be part of a forward-thinking team that drives preclinical excellence in drug-device R&D
Thrive in a culture that values courage, focus, and never settling for mediocrity
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