Toxicologist

Job Description: Toxicologist / Preclinical ScientistWe are seeking a skilled Toxicologist / Preclinical Scientist to join our team. The ideal candidate will be accountable for conducting toxicological risk assessments and overseeing preclinical experimental research.1. Key Responsibilities: Toxicological Risk Assessments
• Derive Health-based Exposure Limits & 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.2. Key Responsibilities: 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.Qualifications and Skills
• Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field.
• Minimum 3-5 years of experience in toxicological risk assessment & experimental toxicology within the pharmaceutical, CRO or biotechnology industry.
• Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions.
• 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, work from office
• Shifts: General shift (8 hours)
• Travelling: Rare/Occasional for outdoor duties/ monitoring

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