Toxicologist

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