Senior Toxicology Specialist

2 days ago

Mumbai, Maharashtra, India beBeeToxicologist Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Opportunity

We are seeking an accomplished Toxicologist/Preclinical Scientist to contribute their expertise in toxicological risk assessments and preclinical experimental research. The ideal candidate will be accountable for conducting thorough toxicological risk evaluations and overseeing complex preclinical experimental projects.

Key Responsibilities:

  • Toxicological Risk Assessments
    • Derive Health-based Exposure Limits and support occupational hazard assessment for pharmaceutical molecules, ensuring adherence to regulatory standards.
    • Conduct comprehensive Toxicological Risk Assessments for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products.
    • Evaluate Genotoxicity Hazard Assessments for impurities using published or experimental in-vitro/in-vivo data and in-silico (Q)SAR tools according to ICH M7 guidelines.
    • Analyze extractable and leachable impurities using literature review and in-silico tools.
    • Determine Harmful Doses for children to inform selection of blister packaging.
  • Experimental Toxicology & Preclinical Research
    • Develop strategic approaches supporting 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.
    • Compile toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions.

Requirements and Skills

  • Bachelor's degree in a related field, such as Toxicology, Pharmacology, Zoology, or Veterinary Medicine.
  • Minimum 3-5 years of experience in toxicological risk assessment and experimental toxicology within the pharmaceutical, CRO, or biotechnology industry.
  • Strong understanding of regulatory guidelines and experience with regulatory submissions.
  • Able to manage multiple projects simultaneously and work effectively in a dynamic team environment.
  • Excellent communication skills with the ability to collaborate cross-functionally and interact with external partners.
  • Detail-oriented with proactive planning abilities, coupled with strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills.
  • Skilled in using computer software, including Microsoft Office suite and relevant applications.

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