Research Scientist II – Biocompatibility

Research Scientist II – Biocompatibility

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.
• 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.
• 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.

Preferred Qualifications

• DABT or eligible to obtain DABT a plus.
• Clinical (veterinary) medical education a plus.