Research Associate Iii

4 days ago

Ahmedabad Gujarat, India BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Position Title - Research Associate III (Pre Clinical, Pharma R&D)**:
Job Location - Ahmadabad

**About Us: Baxter's Mission**:
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we build a place where we are happy, successful and encourage each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Your Role at Baxter**:
**This is where your work saves lives**

As a research scientist in this role will have expertise in toxicology including design, development and monitoring of toxicity studies, evaluation of extractables and leachables from for drug/drug packaging systems assessment of drug product impurities, and authorship of toxicological risk assessments.

**Responsibilities**:
Design, plan, supervises 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).

Work independently on health hazard evaluation of chemicals and develop appropriate strategies for addressing gaps in information, as appropriate. 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 striven for completion of projects with effective partnership and results.

Maintain and reciprocate current knowledge of relevant regulatory requirements related to toxicology, product development, design, and safety as per Baxter’s business needs..

Work with Engineering, R&D, Regulatory, etc. teams to develop comprehensive testing strategies.

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

Prepare and/or review nonclinical eCTD and PBRER sections and Safety data sheets (SDS) 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. Preparation and review of following:

- Toxicological Risk Assessment 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)

Co-ordinate with external CROs to provide oversight to requested activities and collaborate with functional team members as the need arises to ensure timely execution of tasks.

**Qualifications**:
Use a logical, methodical approach when problem solving, developing solutions and
making recommendations. Work independently and prioritize assignments to meet project schedules.

Ability to craft experiments, supervise toxicology studies, interpret the results, and draw relevant 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 8-12 years of work experience, or Ph.D with experience during thesis (&/or Post-doc) e.g., in or equivalent experience in-vitro and in vivo Pre Clinical pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals, drug packaging system.

**Equal Employment Opportunity**:
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gend

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