Baxter Research Associate Toxicologist Job For MSc Biotech, Apply Online

Baxter Research Associate Toxicologist Job For MSc Biotech, Apply Online

Job Title: Toxicologist-Research Associate III (PreClinical, Kidney Care RnD)

Job ID: JR – 099279

Job Category: Research and Development

Shift: General

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.

Summary:

Scientist/Researcher in this role will have expertise

in toxicology and medical device biocompatibility testing including development of toxicity study design and biocompatibility testing design for drug/drug packaging system/medical device development, monitoring, and development of toxicological risk assessments. The successful candidate will have hands-on experience in hazard evaluation of chemicals used in manufacturing and will participate preparing reports for external regulatory bodies in accordance with ICH and ISO10993-17.

Job Responsibilities:

  1. 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.
  2. Author toxicological risk assessment reports and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17.
  3. Work independently on hazard evaluation of chemical and pesticide used in manufacturing.
  4. 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.
  5. Maintain and reciprocate current knowledge of relevant regulatory requirements related totoxicology, product development, design and safety as per Baxter’s business needs with team members and cross functional teams.
  6. 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.
  7. Prepare and/or review nonclinical eCTD and PBRER sections and Safety data sheets (SDS)
  8. Utilize in silico tools (e.g. Lhasa Derek and Sarah Nexus software) to assess toxicological endpoints.

Qualifications:

  1. The position requires relevant technical knowledge in toxicology and biocompatibility testing.
  2. Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, ISO 10993.
  3. Excellent 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 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

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

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 [email protected] and let us know the nature of your request along with your contact information.

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