Job Description

Vantive: A New Company Built On Our Legacy



Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive• will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.



At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

• Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

About Baxter


Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Job Summary

• Job Title - Research Scientist I (PreClinical, Kidney Care RnD)
• Location - Whitefield, Bangalore
• Shift - General

Summary:


The Research Scientist I of Preclinical (Toxicology and Biocompatibility) will contribute to a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration. This individual will apply expertise in product safety evaluation including toxicity study design (for API and impurities) and medical device biocompatibility testing design for drug/drug packaging system/medical device development, monitoring, and development of toxicological risk assessments. The successful candidate will have experience in hazard evaluation of chemicals used in manufacturing and will prepare documents for external regulatory bodies in accordance with ICH and ISO10993-17. This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries).

Job Responsibilities:


Apply state of the art relevant regulatory requirements in designing various GLP toxicity studies, biocompatibility studies, qualification of impurities, leachables, extractables, residual solvents and excipients with minimal supervisions from direct manager and senior members of the organization. Planning and monitoring studies placed at external testing facilities independently Author toxicological risk assessment reports and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17. Work independently on hazard evaluation of chemical used in manufacturing Participate as preclinical/toxicology representative and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects with effective collaboration and deliverables. Participate in change control management and impact assessment. Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement. Prepare and/or review nonclinical eCTD and PBRER sections and Safety data sheets (SDS) Utilize in silico tools to assess toxicological endpoints.

Qualifications
==================


The position requires relevant technical knowledge in toxicology and biocompatibility testing. Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, 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/Biotechnology (or relevant) with 13+ years of relevant work experience, or PhD with 8 years of relevant experience in •in vitro• and •in vivo• pharmacological and toxicological studies (preferably sterile injectable/parenteral formulations), biocompatibility testing of medical devices and drug packaging system, and risk assessment of chemicals.

Skills
==========


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. Solid 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, disability/handicap status or any other legally protected characteristic.


Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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.


134615