Senior Scientist, I: Biocompatibility

Job Description

The Sr Scientist I - Biocompatibility is an SME who will support biocompatibility evaluation requests related to marketed products for AbbVie global medical devices. This includes interfacing with AbbVie manufacturing site change requestors to lead change control activities, organize timely assessments with the biocompatibility team, ensure related documentation regulatory compliance and completion of assessments in change control platforms. This role requires expertise in ISO 10993, medical device regulations, and formal change control processes/platforms, with a strong focus on technical writing, controlled documentation.

In addition, this individual will be responsible for creation (with minimal supervision) and delivery of biocompatibility training and continuing education for internal stakeholders. Must possess knowledge of ISO-10993 Standards and quality management systems, with prior experience working in in marketed product support for medical devices. The position will be responsible for global cross-functional and cross-site collaborations primarily among the manufacturing sites and related product lifecycle functions. Additional support for projects in development for biocompatibility activities is a responsibility of this role.

• Change Control/Marketed Product support:

• Support for on-market products, including global change-control activities as they relate to biocompatibility. Build and maintain strong connections/relationships with cross-functional change control requestors at global manufacturing sites.
• Demonstrated experience with review and evaluation of changes through formal change control systems for biocompatibility impact.
• Hold recurring change control meetings with the sites to ensure changes are being assessed with agility.
• Function as Subject Matter Expert for biocompatibility assessment with minimal supervision

• Project Support:

• Provide skilled technical knowledge to support cross-functional project
• Biocompatibility resource for projects when required.
• Interface with CRO’s for project support initiatives

• Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses.

• Regulatory Compliance:

• Lead change plans for ISO 10993 gap assessments for the organization, liaising with product sites for impact assessments.
• Review and triage departmental (Dev. Sci.) impact assessment notifications.
• Have knowledge on how to support notified body and internal audits, inspections, with respect to ISO 10993 compliance and documentation.
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices.

• Training:

• Prepare and deliver technical presentations to internal and external stakeholders and teams related to biocompatibility, change control, and documentation practices.
• Assist the biocompatibility team in development of functional training initiatives.
• Create a recurring training schedule for biocompatibility and change control

Qualifications

Education and Experience

• Bachelor’s Degree in Life Science or related field with minimal 10 years of experience in a scientific role in the medical device or pharma industry OR Master’s degree (with thesis) in Life Science or related field with at least 8 years of experience in a scientific role in the medical device or pharma industry.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting marketed products is preferred, including change control processes
• Significant experience and knowledge of medical devices and combination product regulations
• Strong technical writing and verbal communication skills; ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
• Strong training and education experience
• Knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Highly self-motivated and proactive; ability to execute with minimal supervision and direction. Can work independently or part of a team.
• Author internal documentation, including procedures and work instructions.
• Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation.
• Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO-10993 standards.
• Proficient in required software change management platforms, Electronic Data Management Systems, and the Microsoft suite of programs.

Additional Information

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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