Research Scientist II - Biocompatibility

Baxter International • Riverwoods, IL

252d • $144,000 - $198,000

About The Position

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 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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• Medical and dental coverage that start on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays.
• Paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree