Research Scientist II - Biocompatibility

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.

The Research Scientist II designs and executes non-clinical safety, medical device biocompatibility, and efficacy strategies to assure user and patient safety through the application of current pre-clinical science, biological evaluation, and toxicological principles in support of new product development and sustaining product initiatives. This is a cross functional position supporting Baxter's Advanced Surgery business which will engage with global internal and external stakeholders to drive projects and initiatives forward.

Supports innovation initiatives by providing technical direction and ensuring the quality of work by applying state-of-the-science theory while integrating pragmatic approaches in a cross-disciplinary fashion to enhance and advance innovation. Externally engages in scientific organizations and forums to integrate and apply current scientific and regulatory thinking into evaluations and assessments.

May be engaged in standards organizations and/or regulatory committees to ensure emerging regulations are based on well-established science and toxicological principles. Keep up to date on regulatory requirements and assess the impact of new standards and/or regulations to enable the generation of appropriate preclinical strategies.

What you'll be doing:

• Develop biocompatibility testing strategies to qualify materials according to global guidelines (including FDA and EU MDR). Author biological evaluation and biocompatibility assessments and work with cross-functional team members (material science, engineering, extractables and leachables, etc.) in order to determine a comprehensive testing strategy.
• Develop and author Biological Evaluation Reports and responses to submission deficiencies/questions (e.g., 510K, PMA, EU MDR).
• Lead 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.
• Implement the use of ISO 10993 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.
• Provide technical and strategic input to meet business objectives at the project team level while assuring compliance with Baxter and external standards.
• Assume responsibility for cost and timelines of projects and establishes business/technical objectives at the project level.
• Aid in study design and monitoring of GLP safety and efficacy studies as well as medical device and combination product Extractable & Leachable studies.
• Author or assist in authoring toxicological risk assessments to support the biological evaluation of medical devices and/or combination products.
• 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 identify relevant information to support product development and registration.
• Function as Study Monitor for outsourced studies (Biocompatibility/Efficacy/Proof-of-concept).
• Assist during off-site preclinical activities, which may include clinical management, animal welfare oversight, product user interactions, surgical plan development and logistics. Provide clinical and surgical knowledge to R&D teams from various disciplines.

What you'll bring:

• Bachelor's degree in a scientific discipline with 13+, MS 10+ years, or PhD (DVM) 4-6+ years of relevant experience in R&D and/or GLP environments.
• The position requires relevant technical knowledge in biocompatibility and general understanding of material physical and chemical properties. Clinical (veterinary) medical education a plus.
• 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.
• 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 and combination 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 required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements.At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

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. 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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 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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