Toxicologist - Research Associate Iii, Pre-clinical

1 week ago

Bengaluru, Karnataka, India BAXTER Full time

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.

Job Summary
-
Job Title
Research Associate III (PreClinical, Kidney Care RnD):-
Location
Whitefield, Bangalore:-
Shift
General
Summary:

Responsibilities:

  • Design, plan, monitor various GLP toxicity studies, biocompatibility studies, risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents and excipients) and safety data sheet related activity with some supervisions from direct manager and senior members of the organization.
  • Work independently on hazard evaluation of chemical and pesticide 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.
  • 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.

  • 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 (e.g. Lhasa Derek and Sarah Nexus software) to assess toxicological endpoints.

Qualifications:

  • The position requires relevant technical knowledge in toxicology and biocompatibility testing.
  • 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 8 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, biocompatibility testing of medical devices, drug packaging system.


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.
  • 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

Reasonable Accommodations

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