[New Job Opening] Toxicologist – Research Associate III, Pre-Clinical job Vacancy in Bengaluru, Karnataka


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Job Details:
Position Name :
Toxicologist – Research Associate III, Pre-Clinical
Bengaluru, Karnataka
Job ID :
Description : 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.
Toxicologist – Research Associate III, Pre-Clinical
Job Summary
Scientist with experience & expertise in toxicology and product safety evaluation including development of nonclinical
plans for drug / device development, development & review of toxicology risk assessments, toxicology and impurity study
design development and monitoring. Hazard evaluation of chemicals used in manufacturing. In-depth knowledge in
Essential Duties and Responsibilities
1. Generation of toxicology risk assessment in accordance with ICH and ISO10993-17.
2. Hazard evaluation of chemical and pesticide used in manufacturing
3. Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design
and safety.
4. Perform as preclinical/toxicology representative on project teams
5. Utilize Lhasa Derek and Sarah Nexus software to assess toxicological endpoints.
6. Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple
variables, and require advanced techniques within negotiated deadlines.
7. Devise new approaches to complex problems through adaptations and modifications of standard technical principles.
Incorporate new methods and technologies for improving existing or new products/processes
8. Independently develop toxicology risk assessments using innovative solutions to address safety through the use of
multiple disciplines and technical principles.
9. Independently review literature and identify relevant articles to support product development and registration.
10. Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, and technical advisor
to junior members within the discipline.
11. Independently plan, execute and manage projects/programs that both span multiple disciplines and incorporate novel
methods, techniques or approaches.
12. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods
and technologies are required. Generate innovative solutions to highly complex problems where little clear
precedence exists.
13. Incorporate advanced theories, methods and technologies from around the world to develop new innovative
14. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able
to 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.
15. Manage projects to coordinate biological safety testing for Baxter’s product portfolio.
16. Utilize Siemens Teamcenter Unified global material management system (GMMS) for biocompatibility testing and
product development and registration support.
17. Develop project schedules; provide estimates and timelines to meet project milestones.
18. Perform biocompatibility assessments in Trackwise 8 and work with cross functional team members in order to
determine a comprehensive testing strategy
1. The position requires relevant technical knowledge in toxicology and safety evaluation. General understanding of
pharmacology highly desired.
2. Ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH guidance, ISO10993.
3. Good oral and written communication in English language.
4. Utilize a logical, methodical approach when problem solving, developing solutions and making recommendations.
5. Ability to work independently and prioritize assignments to meet project schedules.
6. Ability to make routine decisions independently.
7. Ability to design experiments, monitor toxicology studies, interpret the results and draw meaningful conclusions from
the data
Education and Experience:
Ph.D. or Master of Veterinary Science/ Pharmacology/Life-sciences with 8-12 years of work experience of in vivo and/or
vitro Pre-Clinical toxicological evaluations and risk assessment. Candidate with DABT certification will be preferred.
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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