Team member – Toxicologist – GTI Risk assessment

Job Description: Team member Toxicologist GTI Risk assessment

1. Key Responsibilities: Toxicological Risk Assessments

• 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.
• Perform nitrosamine evaluations to derive the limits or read across assessments based on recent global guidelines
• Conduct Toxicological Risk Assessments (TRA) for pharmaceuticals, excipients, intermediates, chemicals, cleaning agents, residual solvents, elemental impurities, and degradation products.

Qualifications and Skills

• Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field.
• OR - Medicinal chemistry background with GTI evaluation, QSAR evaluation nitrosamine evaluations
• Minimum 2-5 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