Toxicologist

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.

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