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Research Scientist 1- Change Control and Risk Management E&L

Req #: JR - 036528 Location Round Lake, Illinois, United States Job Category: Research and Development Date Posted: 03/12/2021

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.

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Research Scientist 1- Change Control and Risk Management E&L

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. 

The Renal Solutions Extractables and Leachables (E&L) team applies subject matter expertise to sustain life saving products on the market and ensure progression of the diverse product portfolios of Baxter’s Renal Care and Acute Therapies businesses. The primary purpose of this position is to apply scientific and risk based approaches to chemical characterizations related to E&L. Responsibilities include contributing to the design and execution of E&L strategies, risk assessments, change controls and studies that address the risk associated with patient exposure to leachables originating from materials used to manufacture, package and deliver either new or existing products.

Essential Duties and Responsibilities

  • Develop strategies to effectively apply a risk based scientific approach within a regulatory framework supporting extractables & leachables projects and change control activities.
  • Evaluate potential extractables/leachable risk according to ICH Q9 and EN ISO 14971 and develop mitigation plans.
  • Perform E&L change control impact assessments and work with cross functional team members (design owners, materials, preclinical, etc.) to determine a comprehensive testing strategy.
  • Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs.
  • Collaborate with a multidisciplinary team of subject matter experts (e.g. Materials, Biocompatibility, and Toxicology) to develop E&L strategies that align to regulatory requirements for medical devices and drug products.
  • Have understanding of state-of-the -art chemical characterization ( ISO 10993:18), evaluations and extractables & leachables assessments for devices.
  • Writing impact assessments, gap assessments, technical rationale's and documents related to E&L.
  • Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design and safety.
  • Contribute to the long-term scientific strategy of the department by proposing novel processes/methods and supporting the development of products.


Qualifications

  • Bachelors degree in scientific discipline (Analytical or Organic chemistry preferred) with at minimum 15 years experience, or MS with at minimum 10 years of experience or PhD with at minimum 3 years of relevant experience.
  • Demonstrated experience in applying risk management methods and tools as part of R&D
  • Knowledge of regulatory expectations related to E/L.
  • Performing change control in a GMP environment.
  • Experience in Environmental Chemistry testing, Compendial Materials testing, or E&L testing preferred.
  • Experience working in global cross-functional teams and project oversight.
  • Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
  • Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met. Effectively communicate with internal and external stakeholders.


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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.

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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.

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."

Reagan

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."

Karthik

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."

Amitha

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.

Reagan

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."

Karthik

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."

Amitha

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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