Toxicology Specialist

2 days ago

Mumbai, Maharashtra, India beBeeToxicology Full time ₹ 80,00,000 - ₹ 1,60,00,000

Job Title: Toxicologist

Role Overview

The primary responsibility of a Toxicologist is to conduct thorough risk assessments and oversee preclinical experimental research.

Key Responsibilities:

  • Derive Health-based Exposure Limits and support occupational hazard assessment for pharmaceutical molecules in accordance with regulatory standards.
  • Conduct comprehensive Toxicological Risk Assessments for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products.
  • Perform Genotoxicity Hazard Assessments for impurities using published or experimental in-vitro/in-vivo data and in-silico (Q)SAR tools as per ICH M7 guidelines.
  • Evaluate extractable and leachable impurities utilizing literature review and in-silico tools.
  • Determine Harmful Doses for children to guide selection of blister packaging.
  • Develop strategic plans supporting differentiated product development.
  • Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for complex/differentiated products and impurity qualifications.
  • Plan, outsource, oversee, and interpret in vivo/in vitro biocompatibility studies for medical devices.
  • Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products.
  • Summarize toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions.

Benefits

This role offers the opportunity to contribute to the development of innovative products and services while advancing knowledge in the field of toxicology.

Requirements:

  • Advanced degree in Toxicology or related field.
  • Proven experience in conducting toxicological risk assessments and overseeing preclinical experimental research.
  • Excellent communication and project management skills.

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