AbbVie · 1 day ago
Scientist I - Biocompatibility
Branchburg Township, NJ, US
Full-time
Onsite
Entry, Mid Level
2+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Scientist I - Biocompatibility role involves providing support for biocompatibility evaluations of medical devices and collaborating with cross-functional teams to ensure compliance with regulatory standards.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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
Qualification
Required
Bachelor's Degree with typically 5 years of experience, OR Master's Degree with typically two years of experience
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)
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
Preferred
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
Familiarity with the product development process for medical devices or biologics
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-23
2026-01-20
2026-01-20
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