Research Scientist Ii, Pre-clinical Toxicology
2 months ago
**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.
**Summary**
- Applies knowledge of pre-clinical safety regulatory requirements as they relate to pharmaceutical product submissions to both national and international markets (e.g., USFDA, EMA and ICH guidelines).
- Provides technical and strategic input to meet business objectives at the project team level while assuring compliance with Baxter and external standards
- Leads and authors pre-clinical sciences and/or toxicology deliverables and activities in support of global project teams at the project team level.
- Based on significant technical expertise, plans, and manages projects, prioritizes personal workload and responsible for meeting R&D objectives, which is shared with other project team members and R&D management.
- Evaluates technical and scientific information, identify deficiencies, implement, and execute strategies to assess and manage potential risk.
- Assume responsibility for the complexity, cost, and deliverables in accordance with timelines for projects and establishes business/technical objectives at the project level.
- May be engaged in standards organizations and/or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles. Assess impact of new standards and/or regulations and provide feedback to the Pre-Clinical Toxicology department and cross-Function.
- Conducts research and authors toxicological risk assessments as they relate to safety evaluation of impurities, leachables and residual solvents. This role will also lead initiation and monitoring of GLP impurity qualification and pre-clinical / non-clinical safety studies conducted at external contract research labs.
- May be engaged in standards organizations and/or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles.
Additional responsibilities may include support of projects and Global Pharmaceutical initiatives involving R&D, Clinical, Medical Affairs, Patient Safety, Regulatory Affairs, Quality, Manufacturing and/or Environmental, Health and Safety.
**Essential Duties and Responsibilities**
- Provide support to function strategy and communicate Pre-Clinical Toxicology vision, goals, and performance to project teams. Support high standards and execute on stretch goals for organization. Escalate barriers to outstanding performance. Hold team and cross-function colleagues accountable for successful completion of projects/tasks.
- Establish technical objectives for projects and programs that may be cross-functional and/or cross-business segment which incorporates critical thinking and breadth of knowledge within Toxicology.
- Provide scientific leadership within project teams and guide prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
- Develop budgets at the project level to ensure the best utilization of financial resources.
- Execute on operational excellence methods and principles to make process improvements in Pre-Clinical processes and cross-function workflows.
- Balance workload based on prioritization; identify opportunities to cross-train and back-fill where necessary. Develop recommendations for external resources as required for the team or project; present internal vs. external analysis.
- Understand and communicate to team members about marketplace dynamics, regulatory changes, and/or scientific thinking that may influence projects and business plans.
- Provide support to manufacturing in change control initiatives and safety evaluation for field actions and batch dispositions as required.
- Demonstrated technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
- Author toxicological risk assessments as they relate to safety evaluation of impurities, leachables and residual solvents, Non-Clinical Overviews and other pharmaceutical regulatory submission documents in accordance with CTD format, Permissible Daily Exposure derivation reports in support of cleaning validations, and Environmental Risk Assessments for medical products.
- Build professional networks internally (cross-functionally and across the Global
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