Scientist I - Biocompatibility

Role Summary

The Scientist I - Biocompatibility provides highly skilled support for biocompatibility and nonclinical safety evaluations of medical devices, tissue products, and combination products as part of AbbVie Research & Development. The role involves supporting cross-functional and cross-site collaborations with recommendations for biocompatibility activities under limited supervision.

Responsibilities

• Responsible for supporting Project Plans for biocompatibility with realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety and efficacy characterization of new and existing products.
• Function as a representative for ISO-10993 (biocompatibility) assessments, with supervision from Biocompatibility senior team members and therapeutic area SMEs. This will include the design, execution, and interpretation of biocompatibility evaluation strategies per the applicable regulatory requirements, including biological risk assessments and management of required studies and documentation outputs.
• Serve as dedicated biocompatibility resource for product development teams, working closely with other colleagues in Development Science. Provide skilled technical knowledge to support cross-functional project initiatives.
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
• Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses. Author and review Biocompatibility documentation for internal and external distribution with minimal supervision.
• Support global change control activities as they relate to Biocompatibility.
• Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.

Qualifications

• Bachelor’s Degree with typically 5 years of experience, OR Master’s Degree with typically two years of experience.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success in supporting studies for R&D projects is preferred.
• Experience and working knowledge of medical device and combination product regulations
• Working knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Strong technical writing and verbal communication skills.
• Self-motivated; ability to execute with minimal supervision and direction. Can work independently or part of a team.
• Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
• Familiarity with the product development process for medical devices or biologics
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Knowledge of Good Documentation Practices and maintain accurate documentation, record retention documentation. Knowledge of Good Laboratory Practices (21 CFR, Part 58)
• Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software.