Summary

· Job Title – Research Associate II (PreClinical, Pharma RnD)

· Location – GPRD, Ahmedabad

Scientist/Researcher in this role will have expertise in toxicology including design, development and monitoring of toxicity studys, evaluation of extractables and leachables from for drug/drug packaging systems assessment of drug product impurities, andauthorship of toxicological risk assessments. The successful candidate will have hands-on experience in hazard evaluation of chemical entities, and impact assessment of manufacturing or supplier changes, as well as participate in preparing reports for external regulatory bodies in accordance with ICH and ISO guidelines/standards.

Job Responsibilities:

1. Design, plan, monitor various outsourced in vitro and in vivo GLP toxicity studies, perform risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents and excipients) related activities with some supervision from direct manager and senior technical lead(s).

2. Independently author toxicological risk assessments in accordance with ICH and ISO guidelines/standards, as well as local regional regulatory guidelines, by utilizing a multidisciplinary approach to addressing complex issues. 

3. Work independently on health hazard evaluation of chemicals and develop appropriate strategies for addressing gaps in information, as appropriate.

4. Participate as preclinical/toxicology representative and contribute to core technical team meetings as Subject Matter Expert (SME) and provide inputs and lead tasks to be executed for completion of projects with effective collaboration and deliverables.

5. Maintain and reciprocate current knowledge of relevant regulatory requirements related to toxicology, product development, design, and safety as per the business needs with team members and cross functional teams.

6. Work with cross functional team members (Engineering, R&D, Regulatory, etc.) to develop comprehensive testing strategies.

7. Participate in change control management and impact assessment. Propose options, work closely with stakeholders, and develop action plans for problem-solving, product and process improvement.

8. Prepare and/or review nonclinical eCTD and PBRER sections and Safety data sheets (SDS)

9. Analyze and address issues related to data gap for toxicity endpoints using in-silico tool (e.g. Derek Nexus and Sarah Nexus) and read across based assessments.

10. Preparation and review of following:

• Toxicological Risk Assessment (TRA) for extractables, leachables, residual solvents, elemental impurities, impurities and degradation products

• Impurity qualification

• Nonclinical Overview and Summaries (Module 2.4 and 2.6) 

• Permissible Daily Exposure (PDE) document 

• Non-clinical section of Risk Management Plan (RMP)

11. Co-ordinate with external CROs to provide oversight to requested activities and communicate with functional team members as required to ensure timely execution of tasks.

Qualifications:

1. The position requires relevant technical knowledge in toxicology. 

2. Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH guidelines, and ISO 10993.

3. Excellent oral and written communication in English language.

4. Utilize a logical, methodical approach when problem solving, developing solutions and 

making recommendations.

5. Ability to work independently and prioritize assignments to meet project schedules.

6. Ability to design experiments, monitor toxicology studies, interpret the results, and draw meaningful conclusions from the data and prepare reports for external regulatory bodies.

Education and/or Experience:

Master of Medical Sciences/ Veterinary Sciences/ Pharmacology/ Toxicology/ Biochemistry Biotechnology (or relevant) with 6-9 years of relevant work experience, or PhD with relevant experience during thesis (&/or Post-doc) e.g., in in vitro and in vivo PreClinical pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals, drug packaging system.

Preferred: 

• DABT or ERT certification

• Previous experience in pharmaceutical or medical device toxicological risk assessment

Skills

1. Demonstrated competency and experience with toxicological principles and applications.

2. Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders, Fluency in English.

3. Can effectively communicate with internal and external customers.

4. Good computer skills: email, good documentation practice, and collaboration tools: e.g., Zoom, Teams, Microsoft Office products, etc.

5. Demonstrated ability to work in a matrix environment with multiple stakeholders

6. Demonstrates flexibility and the ability to shift gears between projects comfortably.

7. Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables