Job Description: Toxicologist / Preclinical Scientist We 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
Job Title
Toxicologist