Team member – Toxicologist – GTI Risk assessment

Job Description:

Team member – Toxicologist – GTI Risk assessment

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