Principal Research Scientist I, Tissue Material Sciences Fillers

Principal Scientist I

The Principal Scientist I in the Tissue Materials Science group is responsible for directing research and/or project activities and professional development of a group of scientists within TMS by effectively mentoring, guiding and/or supervising scientific personnel. He/She/They independently conceive, execute and communicate novel multi-disciplinary research or development strategies that achieve project for the Fillers device franchise, including Juvderm and Next Generation Dermal Fillers, pre-concept (early research) and new model development. The focus of such studies will be to evaluate the interaction of current and future medical devices with cells and tissues for purposes of establishing device proof of concept, completing regulatory submission-related studies (ISO 10993), performing life cycle compliance-related activities, and developing scientific messaging for advertising/promotional support. This individual is expected to be a team leader and engage key stakeholders, including global strategic marketing, medical affairs, regulatory affairs, clinical development, and publication planning to successfully achieve project goals. The individual serves as a lead scientist on his/her/their own project and contribute scientific insights into multiple other projects.

The Principal Research Scientist I may mentor/supervise a team of one or more direct reports and evaluate the performance of those individuals. Additionally, the individual is accountable for the effective performance of the team/individuals.

Key Duties / Responsibilities

• Scientific Leadership
• Function as a principle investigator/lead, generating original technical ideas and research or development strategies.
• Represents TMS in cross functional teams to provide technical leadership for design, analysis and reporting for pre-concept or development programs and drive alignment with functional management.
• Authors publications, presentations and/or primary inventor of patents.
• Serve as a technical advisor and subject matter expert in his/her/their discipline.
• May be required to mentor/train/manage junior staff in a matrix based organization or as part of a project team.

• Scientific Execution
• Demonstrate creative "out of the box" thinking to solve difficult problems and champion new technologies to achieve project goals.
• Develops and executes in vitro, in vivo and tissue processing methods to support development of novel medical device/tissue products.
• Critically evaluate scientific or regulatory advances, competitive threats or business development opportunities.

• Scientific Communication
• Serves as a technical advisor and subject matter expert in his/her/their discipline to management and internal customers, driving alignment with cross-functional Asset teams and management for activities and deliverables.
• May contribute to publications, regulatory documents and inventions and present at external conferences.
• Provides regular updates to manager and project teams, contributes and prepares technical reports for the department and management as needed.

• Cross-Functional Team Representation
• Critical team member in Asset Strategy, involved in developing project strategy
• Serves as TMS representative on Asset teams, Strategy teams and product development subteams, providing expertise in areas of tissue responses to Fillers.
• Supports Design Control activities as the non-clinical representative on development teams with minimal guidance.
• Organizes, schedules, and participates in project team meetings to define and schedule project activities and review completed tasks.
• Communicates project status to supervisor, project team leader, other research managers, and R&D committees as appropriate.
• Prepares time and cost estimates of project activities for review by manager to achieve realistic project completion dates

Qualifications

• Ph.D. and a minimum of 6+ years of industry experience OR Master's degree and 12+ years of industry experience OR BS and 14+ years of industry experience;. Degree in a related scientific or engineering discipline (cell biology, molecular biology, pharmacology, immunology, bioengineering, or similar)
• 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 conducting R&D projects
• Experience and working knowledge of medical device, drug and/or biologics, and combination product regulations (21 CFR 820, 21 CFR 210/211, 21 CFR Part 4, Biologics, etc.)
• Experience managing outsourced research activities
• Experience managing in vivo and in vitro research activities
• Working knowledge of biocompatibility testing requirements (ISO 10993)
• Experience conducting/managing GLP toxicity and biocompatibility studies is a plus
• Technical report writing proficiency in support of regulatory submissions
• Expertise in small / large animal model study performance and imaging
• Creativity, strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to detail are essential skills for this position
• Able to multitask and work within timelines.
• Able to build strong relationships with peers and cross-functional partners to achieve higher performance.
• Proficiency in mentoring junior staff or serving as a senior technical advisor.

The employee must conduct their work activities in compliance with all AbbVie, Irvine internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. AbbVie, Irvine internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.