Senior Scientist, I: Biocompatibility
About The Position
The Senior Scientist I - Biocompatibility is a subject matter expert who supports biocompatibility evaluation requests for AbbVie global medical devices, primarily for marketed products. The role interfaces with manufacturing-site change requestors, leads change-control activities, coordinates timely assessments with the biocompatibility team, and ensures regulatory compliance and completion of related documentation in change-control platforms. It requires expertise in ISO 10993, medical device regulations, formal change-control processes and platforms, technical writing, and controlled documentation. The position creates and delivers biocompatibility training and continuing education for internal stakeholders with minimal supervision. It collaborates globally across functions and sites, primarily with manufacturing sites and product-lifecycle functions, and also supports biocompatibility activities for development projects. Responsibilities include evaluating change-control requests for biocompatibility impact, supporting projects and regulatory submissions, coordinating with contract research organizations, contributing to regulatory and audit readiness, and developing training materials and schedules.
Requirements
- Bachelor’s degree in Life Science or a related field and at least 10 years of experience in a scientific role in the medical device or pharmaceutical industry; alternatively, a master’s degree with thesis in Life Science or a related field and at least 8 years of such experience.
- Knowledge of ISO 10993 standards, FDA guidance and regulations, and Animal Welfare Regulations.
- Knowledge of Good Laboratory Practices (21 CFR, Part 58).
- Knowledge of Good Documentation Practices and accurate documentation and related record-retention documentation.
- Strong technical-writing and verbal-communication skills, including the ability to explain complex technical information clearly.
- Strong training and education experience.
- Critical-thinking and problem-solving skills, including the ability to analyze and present data.
- Ability to work proactively and with minimal supervision, independently or as part of a team.
- Proficiency with required software change-management platforms, electronic data-management systems, and Microsoft programs.
Nice To Haves
- Medical device, pharmaceutical, or related experience, or experience in a regulated environment, with a proven record of supporting marketed products, including change-control processes.
- Significant experience and knowledge of medical devices and combination-product regulations.
Responsibilities
- Support global change-control activities for marketed products as they relate to biocompatibility.
- Build and maintain relationships with cross-functional change-control requestors at global manufacturing sites.
- Review and evaluate changes through formal change-control systems for biocompatibility impact.
- Hold recurring change-control meetings with manufacturing sites to ensure changes are assessed promptly.
- Serve as a biocompatibility subject matter expert with minimal supervision.
- Provide technical biocompatibility support to cross-functional projects and serve as a resource for projects when required.
- Interface with contract research organizations for project-support initiatives.
- Work with the Biocompatibility Team and device project teams to generate regulatory-submission documentation and support regulatory responses.
- Lead organizational change plans for ISO 10993 gap assessments and liaise with product sites on impact assessments.
- Review and triage departmental impact-assessment notifications.
- Support notified-body and internal audits and inspections regarding ISO 10993 compliance and documentation.
- Maintain knowledge of medical device regulations to support compliance and conformance of medical-device evaluation programs.
- Prepare and deliver technical presentations to internal and external stakeholders on biocompatibility, change control, and documentation practices.
- Assist the biocompatibility team in developing functional training initiatives.
- Create a recurring training schedule for biocompatibility and change control.
- Author internal documentation, including procedures and work instructions.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
