Manager, R&D - Biocompatibility
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Manager Biocompatibility is a Subject Matter Expert (SME) related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of AbbVie Device Research & Development. This individual must possess an extensive knowledge of ISO-10993 Standards. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, and manufacturing (product support).
Main Areas of Responsibilities
- Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety and efficacy characterization of novel and existing products May serve as a sub-team or core-team member, providing support as needed for Project Teams.
- Function as a representative for ISO-10993 (biocompatibility) assessment management with supervision from therapeutic area SME. This will include the design, execution and interpretation of biocompatibility evaluation strategies and programs according to relevant regulatory requirements, including biological risk assessments and execution of required studies.
- Serve as a department (TMS) representative for biocompatibility needs. Provide skilled technical knowledge to support cross-functional project initiatives. Support project initiatives at other device sites as needed, including change control evaluations.
- Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device 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.
- Writes, reviews and issues risk assessments, technical reports, technical memoranda and other documents for internal and external distribution. Works closely with AbbVie project teams to generate documentation for regulatory submissions.
- Perform Standards Gap Assessments to support Device organization to maintain compliance.
- Build and maintain strong connections and relationships with outside Contract Research Organizations, Toxicologists and Consultants for Risk Assessments as needed.
- Bachelor’s degree in Life Science/Biomedical Engineering or related field with minimal 6 years’ experience in a scientific role in the medical device or pharma industry or Master’s degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry.
- Knowledge of Good Documentation Practices and maintain accurate documentation, record retention documentation.
- Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO-10993 standards.
- Contribute ideas and suggestions to improve standard laboratory techniques, experimentation efficiency, improve protocols, processes and equipment.
- Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software.
- Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
- Self-motivated; ability to execute with minimal supervision and direction. Can work independently or part of a team.
- Medical device experience or experience in a regulated environment is preferred.
- Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects.
- 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.
- Strong technical writing and verbal communication skills.
- Strong familiarity with the product development process for medical devices or biologics.
- Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
- Author internal reports and procedures as well as collaborating on manuscripts and abstracts for external submissions.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.