Research Associate II (PreClinical, Pharma R&D)

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.  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.

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). Independently author/review 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. 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 executed for completion of projects with effective collaboration and deliverables. Maintain and reciprocate current knowledge of relevant regulatory requirements related to toxicology, product development, design, and safety as per Baxter’s business needs with team members and cross functional teams. Work with cross functional team members (Engineering, R&D, Regulatory, etc.) to develop comprehensive testing strategies. 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. 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 (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) 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: The position requires relevant technical knowledge in toxicology. Demonstrated ability 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. Utilize a logical, methodical approach when problem solving, developing