Senior Research Scientist - Biocompatibility SME

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.

Your Role at Baxter

This is where your work saves lives.

As the Senior Research Scientist / Senior Toxicologist you would be responsible for defining, creating and executing non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product and patient safety and efficacy through the application of current pre-clinical science, biological evaluation, non-clinical safety assessment, and toxicological principles and strategies to enable and support new product development and sustaining product processes and initiatives. You will support the primary Pre-Clinical Toxicology point-of-contact for the assigned Business Segment and/or Division. This is a cross functional position which will engage with global internal and external stakeholders to drive projects forward.

What you'll be doing:

• Provides technical and strategic input to meet business objectives at the project team level while assuring compliance with Baxter and external standards.

• Leads and authors pre-clinical sciences and/or toxicology deliverables (e.g., non-clinical testing plans, toxicological risk assessments, biological evaluation plans and reports) and activities in support of global programs.

• Based on significant technical expertise, plans, and manages complex projects, prioritizes workload and is responsible for meeting major objectives for the organization.

• Evaluates technical and scientific information, identify deficiencies, designs solutions, and executes strategies to remediate risks.

• Assumes responsibility for the size/complexity, cost and timelines of projects and establishes business/technical objectives at the project level.

• Supports innovation initiatives by providing technical direction / input and ensures quality of work deliverables that apply state-of-the-science theory while integrating pragmatic approaches in a cross-disciplinary fashion to enhance and advance innovation.

• May be engaged in standards organizations and/or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles. Assess impact of new standards and/or regulations and provide feedback to the Pre-Clinical Toxicology department and cross-Function.

Essential Duties and Responsibilities

• Author and conduct qualitative or quantitative toxicological risk assessments to support of biological evaluation of medical devices and/or combination products.

• Develop and author Biological Evaluation Reports and responses to submission deficiencies/questions (e.g., 510K, PMA, EU MDR).

• Develop biocompatibility testing strategies to qualify materials according to global guidelines (including FDA and EU MDR). Perform biocompatibility assessments and work with cross functional team members (engineering, extractables and leachables, etc.) in order to determine a comprehensive testing strategy.

• Implement the use of ISO10993 series, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Laboratory Studies, and/or other regulatory guidance documents to qualify Baxter products.

• Provide support to manufacturing in change control initiatives and safety evaluation as required.

• Aid in study design and monitoring of GLP safety and medical device Extractable & Leachable studies for medical device qualification.

• Interpret raw material, finished device data and literature to assess overall risk to patients. Develop justification to address ISO10993-1 endpoints based on study data and literature. Independently review literature and identifies relevant information to support product development and registration.

• Perform as Study Monitor/Study Director for outsourced studies (Toxicology/Efficacy/Proof-of-concept).

What you'll bring:

• The position requires relevant technical knowledge in biocompatibility and general understanding of material physical and chemical properties.

• Ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ISO10993 series, regional compendia.

• Direct experience interfacing with US-FDA, EU Notified Bodies, Competent Authorities and/or other national or international regulatory reviewers.

• DABT or eligible to obtain DABT a plus.

Education and/or Experience

• Bachelor's degree in a scientific discipline with 15+ years of relevant experience, or MS with 10+ years experience, or PhD with at least 3-4 years of relevant experienced required.

• Solid experience in a pharmaceutical and/or medical device GLP and/or R&D environment that includes representing function on technical and scientific teams and working knowledge of project management.

• Demonstrated effective applied expertise to advance new product development projects, achievement of regulatory submission approvals, and providing non-clinical solutions for pharmaceutical and/or medical device product development challenges.

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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $144,000 to $198,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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Pay Transparency Policy

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.

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