Research Scientist I

Vantive Healthcare Technologies; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Vantive Healthcare Technologies in Bangalore is seeking a Research Scientist I to apply toxicology and biocompatibility expertise in GLP studies for drug packaging and medical devices. You will monitor studies, prepare risk assessments, and contribute to regulatory reports in line with ICH and ISO10993‑17.

The ideal candidate has strong experience in hazard evaluation of chemicals and a track record of collaborating with multidisciplinary teams to ensure safety across dialysis and acute

Qualifications

• Master of Life Sciences/related field with 12–15 years’ experience, or PhD with 8–10 years in toxicology and biocompatibility.
• Experience in in vitro and in vivo pharmacology/toxicology tests and risk assessment.
• Familiarity with regulatory guidelines (ICH, FDA GLP) and ISO 10993.

Responsibilities

• Design, plan, monitor GLP toxicity and biocompatibility studies with minimal supervision.
• Author toxicology risk assessment reports on leachables, extractables, solvents, and excipients as SME.
• Issue SDS and conduct hazard evaluation of chemicals used in manufacturing.
• Contribute as SME in cross‑functional team meetings and lead project tasks.

Skills

Toxicology

Biocompatibility

Risk assessment

GLP

ICH

ISO 10993

eCTD

PBRER

In silico

Education

Master of Life Sciences / Veterinary / Biotechnology / Pharmacy (or relevant)

PhD / Post‑doc with 8–10 years of relevant experience

Job description

Job Summary

Job Title - Research Scientist I

Location - Bangalore

Shift - General

The Researcher of Preclinical (Toxicology and Biocompatibility) in this role will apply expertise in toxicology and medical device biocompatibility testing including development of toxicity study design and biocompatibility testing design for drug/drug packaging system/medical device development, monitoring the studies, and development of toxicological risk assessments. The successful candidate will have hands‑on experience in hazard evaluation of chemicals used in manufacturing and will participate in preparing reports for external regulatory bodies in accordance with ICH and ISO10993‑17. This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices for peritoneal dialysis, hemodialysis, and acute therapies.

Responsibilities

• Work independently in designing, planning, monitoring of various GLP toxicity studies, biocompatibility studies, and qualification of impurities with minimal supervision from direct manager and senior members of the organization.
• Work independently as an author for toxicological risk assessment reports on leachables, extractables, residual solvents and excipients and review or concur with toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993‑17.
• Work independently on hazard evaluation of chemicals used in manufacturing and issuing safety data sheet (SDS).
• Participate as preclinical/toxicology representative and contribute to core technical team meetings as SME and provide input and lead tasks to be executed for completion of projects with effective collaboration and deliverables.
• Participate in change control management and impact assessment. Propose options, work closely with stakeholders and develop action plans for problem‑solving, product and process improvement. Prepare and/or review nonclinical eCTD and PBRER sections. Utilize in silico tools to assess toxicological endpoints.
• Independently plan and execute a series of design or technical tasks that may not be well‑defined and have multiple variables within negotiated deadlines.
• Develop new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
• Work with team members and members from cross functional teams, give and accept constructive feedback, resolve conflicts and work as a team to complete projects with quality in defined timelines.

Qualifications

The position requires 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.

Education and/or Experience:

Master of Life Sciences / Veterinary / Biotechnology / Pharmacy (or relevant) with minimum 12-15 years of relevant work experience, or PhD /or Post‑doc with 8-10 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.

Skills

• Toxicology
• Biocompatibility
• Risk assessment
• GLP
• ICH
• ISO 10993
• eCTD
• PBRER
• In silico