Toxicity Research Specialist

24 hours ago

Mumbai, Maharashtra, India beBeeResearch Full time ₹ 9,00,000 - ₹ 12,00,000

Job Description

We are seeking a skilled Toxicity Research Specialist to join our organization. The ideal candidate will be accountable for conducting toxicological risk assessments and overseeing preclinical experimental research.

Main Responsibilities:

  • Derive health-based exposure limits and support occupational hazard assessment (PDE/OEL) for pharmaceutical molecules in adherence to regulatory standards.
  • Conduct toxicological risk assessments (TRA) 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 according to ICH M7 guidelines.
  • Evaluate extractable and leachable impurities using literature review and in-silico tools.
  • Determine harmful doses for children to guide selection of blister packaging.

Experimental Toxicology & Preclinical Research

  • Develop preclinical strategies 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.

Requirements:

  • An advanced degree in toxicology, pharmacology, zoology, veterinary medicine, or a related field.
  • A minimum of 3-5 years of experience in toxicological risk assessment and experimental toxicology within the pharmaceutical, CRO, or biotechnology industry.
  • A strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions.
  • A proven ability 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 such as CROs.
  • 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 (Word, Excel, PowerPoint), SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications.

Operational Details:

  • Location: Vikhroli, Mumbai.
  • Mode: Full-time, working from an office.
  • Shifts: General shift (8 hours).
  • Traveling: Rare or occasional for outdoor duties/monitoring.

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