Scientist II - Biocompatibility

AbbVie•Branchburg, NJ

15h

About The Position

The Scientist II - Biocompatibility is a SME which will provide highly skilled support for biocompatibility and non-clinical safety evaluations of medical devices, tissue products, and combination products as a part of AbbVie Research & Development. The position will be responsible for supporting cross-functional and cross-site collaborations involving recommendations for biocompatibility activities with limited supervision. This individual must possess a working knowledge of ISO-10993 and other applicable standards. The position will be responsible for supporting cross-functional and cross-site teams and recommendations of biocompatibility activities. This includes establishing requirements, planning, execution, and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on marketed product support.

Requirements

Bachelor’s Degree in Life Science/Biomedical Engineering or related field with minimal 7 years of experience in a scientific role in the medical device or pharma industry or Master’s degree in Life Science/Biomedical Engineering or related field with at least 5 years of experience.
Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting patient safety studies for R&D projects is preferred.
Experience and working knowledge of medical device and combination product regulations
Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare 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.
Understands sense of urgency with relation to priority projects.
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, maintain accurate documentation & related record retention documentation.
Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO-10993 standards.

Responsibilities

Function as a representative for ISO-10993 (biocompatibility) assessments, with minimal supervision from Biocompatibility senior team members and therapeutic area SMEs. This will include the design, execution, and interpretation of biocompatibility evaluation strategies and programs per the applicable regulatory requirements, including biological risk assessments, technical documentation, and other documents for internal and external distribution and regulatory submissions.
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.
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, inclusive of updating of internal product files for component/process changes.
Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision.
Assist the team in functional training initiatives.
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.