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▷ [Only 24h Left] Toxicologist
2 months ago
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.
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
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