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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxters 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. 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: 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). Independently author toxicological risk assessments in accordance with ICH and ISO guidelines/standards, as well as local regional regulatory guidelines, by applying a multidisciplinary approach to addressing complex issues.
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 Baxters 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: The position requires relevant technical knowledge in toxicology. Proven track record to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH guidelines, and ISO 10993. Excellent oral and written communication in English language. 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 2-6 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, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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