Research Scientist I
On-siteBengaluru, Karnataka, India
Job Summary
Design, plan, and monitor GLP toxicity studies and biocompatibility testing for drug and medical device development while independently authoring toxicological risk assessment reports for external regulatory bodies. Conduct hazard evaluations of manufacturing chemicals, issue safety data sheets, and utilize in silico tools to assess toxicological endpoints. Collaborate with cross-functional teams as a subject matter expert to lead technical tasks, manage change controls, and prepare nonclinical eCTD and PBRER sections. This Research Scientist I role supports Vantive's mission to extend lives through advanced dialysis therapies and vital organ treatments, working within a matrixed environment to drive product and process improvements.
Required Qualifications
- relevant technical knowledge in toxicology and biocompatibility testing
- Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, ISO 10993
- Excellent oral and written communication in English language
- Utilize a logical, methodical approach when problem solving, developing solutions and making recommendations
- Ability to work independently and prioritize assignments to meet project schedules
- Ability to design experiments, monitor toxicology studies, interpret the results and draw meaningful conclusions from the data and prepare reports for external regulatory bodies
- Master of Life Sciences/Veterinary/Biotechnology/Pharmacy (or relevant) with minimum 12 to 15 years of relevant work experience
- PhD &/or Post-doc with 8 to 10 years of relevant experience in e.g., in vitro and in vivo pharmacological (preferably sterile injectable/parenteral formulations), toxicological studies and risk assessment of chemicals, biocompatibility testing of medical devices and drug packaging system
- Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders
- Fluency in English
- Can effectively communicate with internal and external customers
- Solid computer skills: email, good documentation practice, and collaboration tools: e.g., Zoom, Teams, Microsoft Office products, etc
- Demonstrated ability to work in a matrix environment with multiple stakeholders
- Demonstrates flexibility and the ability to shift gears between projects comfortably
- Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables
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