This role supports the Pre-Clinical GPRD team by providing scientific expertise and contributing to the execution of nonclinical safety assessment activities. The successful candidate will possess a strong foundation in toxicology and pharmacology, a working knowledge of current pharmaceutical regulatory requirements (including ICH, ISO, and FDA guidelines), and excellent written and verbal communication skills. Experience in human health hazard evaluation and the practical application of toxicological principles will be considered an advantage.

Key Responsibilities:

- Provide support to senior team members in data management, integration, and related scientific activities.
- Conduct literature reviews, analyze data, and develop compound-specific health hazard profiles.
- Prepare toxicological risk assessments (TRAs) for extractables, leachables, residual solvents, elemental impurities, degradation products, and related substances in accordance with regulatory requirements (FDA, ICH, ISO).
- Design, plan, and monitor in vitro and in vivo toxicology studies conducted at external Contract Research Organizations (CROs).
- Contribute to safety and risk assessments, including impurity qualification and evaluation of excipients and other materials, in collaboration with cross-functional teams.
- Support the preparation of Safety Data Sheets (SDS) and associated documentation.
- Ensure effective cross-functional communication and collaboration to drive timely completion of assigned deliverables.
- Author and support preparation of regulatory and scientific documentation, including: Impurity qualification reports, Nonclinical Overview (Module 2.4)



and Nonclinical Summaries (Module 2.6), Permissible Daily Exposure (PDE), and Nonclinical sections of Risk Management Plans (RMPs)
- Identify and address toxicological data gaps using in silico tools (e.g., Derek Nexus, Sarah Nexus) and read-across methodologies.

Qualifications

Master s/PhD degree in pharmacy or science with specialization in Pharmacology, Toxicology, Medical Sciences, Veterinary Sciences, Biochemistry, Biotechnology, or a related discipline.

Skills

Fundamental understanding of experimental techniques used in toxicological and pharmacological research.

Working knowledge of extractables and leachables (EL) studies.

Basic understanding of QSAR principles and predictive toxicology tools for impurity assessment.

Strong written and verbal communication skills, with the ability to present complex scientific information clearly to global stakeholders. Fluency in English is required.

Familiarity with statistical approaches and data interpretation techniques.

Proficiency in standard computer applications (e.g., Microsoft Word, Excel, PowerPoint).

Strong learning agility with the ability to quickly grasp and apply new scientific concepts.

Demonstrated initiative and accountability in completing assigned tasks within defined timelines.

Ability to work effectively in a matrixed, cross-functional workplace with multiple stakeholders.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Research Associate, R&D Pre-Clinical Toxicology (Ahmedabad)
🏢 BAXTER
📍 Ahmedabad