BAXTER Hiring for Research Scientist II, Pre-Clinical Toxicology at Ahmedabad, Gujarat Full Time

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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

This Senior Research Scientist position is responsible for defining, creating and executing non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product (patient) safety and efficacy through the application of current pre-clinical science, non-clinical safety assessment, and toxicological principles and strategies to enable and support new product development (NPD), sustaining product organization (SPO) and value improvement projects (VIP) and associated product development lifecycle management (PDLM) processes and initiatives. This position will support the primary Pre-Clinical Toxicology point-of-contact for the Global Pharmaceuticals business segment with the follow the expectations:

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.

Supports innovation initiatives by providing technical direction / input and ensures quality of work deliverables that apply state-of-the-science theory while integrating pragmatic approaches in a cross-disciplinary fashion to enhance and advance innovation.

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.

As subject matter expert, develop innovative solutions to technical problems and apply innovative approaches/leading-edge technologies as well as methods are required. Apply creative theories/concepts leveraging multiple disciplines, state-of-the-science technical expertise (such as Computational Toxicology) principles, and methods to resolve significant technical and scientific challenges.

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 Pharmaceutical segment) and outside of Baxter. Participate on global task forces and committees – foster exchange of technical information with other research and innovation groups inside and outside of the Baxter.

Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design, and safety) to ensure compliance in all research, data generation and reporting activities.

Maintain and grow knowledge and understanding of GxP and related regulations and guidance (ICH Q3A/B, Q3C, Q3D and M7), and provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.

As requested, contribute and/or lead strategic initiatives that drive value within the Global Pharmaceutical business segment and Baxter.

Qualifications

Has proficient knowledge and experience with national and international non-clinical safety / biological evaluation regulations (including Good Laboratory Practices; GLP), regulatory guidance and expectations to enable the conduct of human clinical trials and achieve market approvals of pharmaceutical and/or medical device products.

Demonstrated ability to make and scientifically defend decisions confidently, respectfully, and independently.

Knowledge and experience in supporting the non-clinical safety of generic drug applications and approvals (e.g., USFDA ANDA and 505(b)(2) Applications).

Presentation at external scientific conferences, author/co-author in published scientific articles in peer review journals/books, and/or cited inventor/co-inventor of published patents.

Education and Experience

BS with 13 years, MS with 10 years, or PhD with 4-6 years of relevant work experience in R&D and GLP environments.

Demonstrated effective applied expertise to advance new product development projects, achievement of regulatory submission approvals, and providing non-clinical solutions for pharmaceutical and/or medical device product development challenges.

Solid experience in a pharmaceutical and/or medical device GLP and/or R&D environment that includes representing function on technical and scientific teams and working knowledge of project management.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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