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Research Associate II (PreClinical, Pharma R&D)

Req # 206678 Location Ahmedabad, Gujarat, India Job Category Research and Development Date posted 09/02/2026
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Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Health & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

Research Associate II (PreClinical, Pharma R&D)

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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.


Job Responsibilities:

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 solutions and
making recommendations. Ability to work independently and prioritize assignments to meet project schedules. Ability to design experiments, monitor toxicology studies, interpret the results, and draw meaningful 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 6-10 years of relevant work experience, or PhD with relevant experience during thesis (&/or Post-doc) e.g., in in vitro and in vivo PreClinical pharmacological (preferably sterile injectable/parenteral formulations) and toxicological studies and risk assessment of chemicals,  drug packaging system.

Preferred:

  • DABT or ERT certification
  • Previous experience in pharmaceutical or medical device toxicological risk assessment

Skills

Demonstrated competency and experience with toxicological principles and applications. Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders, Fluency in English. Can effectively communicate with internal and external customers. Good computer skills: email, good documentation practice, and collaboration tools: e.g., Zoom, Teams, Microsoft Office products, etc. Demonstrated ability to work in a matrix environment with multiple stakeholders Demonstrates flexibility and the ability to shift gears between projects comfortably. Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables

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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Navratna Corporate Park
Tower A Ground Floor
Tower B 21st and 22nd Floor
Gujarat- 380058
Gujarāt
India Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

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