Research Scientist I (Toxicology and Biocompatibility)

Location: Whitefield, Bangalore, Karnataka, India. General shift.

Company

hirify.global develops vital organ therapies, dialysis solutions, digital services, and advanced medical technologies to improve outcomes for patients and care teams.

What you will do

• Design, plan, and monitor GLP toxicity, biocompatibility, and impurity qualification studies.
• Author and review toxicological risk assessments for leachables, extractables, residual solvents, and excipients.
• Evaluate manufacturing chemical hazards and issue safety data sheets.
• Represent preclinical and toxicology functions in multidisciplinary technical teams and lead assigned project tasks.
• Support change control, impact assessments, corrective action planning, and product or process improvements.
• Prepare or review nonclinical eCTD and PBRER sections and use in silico tools to assess toxicological endpoints.

Requirements

• Relevant technical expertise in toxicology and medical device biocompatibility testing.
• Experience applying OECD and FDA GLP, ICH Q3, and ISO 10993 guidelines.
• Ability to design experiments, monitor studies, interpret results, draw conclusions, and prepare reports for regulatory bodies.
• Master's degree in Life Sciences, Veterinary, Biotechnology, Pharmacy, or a related field with 12–15 years of relevant experience, or a PhD and/or postdoctoral experience with 8–10 years of relevant experience.
• Experience with in vitro and in vivo pharmacological or toxicological studies, chemical risk assessment, and biocompatibility testing of medical devices and drug packaging systems.
• Fluent English is required for written, oral, and stakeholder communication.

Culture & Benefits

• Work in a highly matrixed, multidisciplinary environment with global stakeholders.
• Collaborate across functions while managing project timelines, budgets, and deliverables.
• Opportunity to contribute to products supporting peritoneal dialysis, hemodialysis, and acute therapies.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.