BioSpace
Principal Research Scientist I, Tissue Material Sciences Fillers
BioSpace, Irvine, California, United States, 92713
Overview
Principal Research Scientist I, Tissue Material Sciences Fillers
role at BioSpace. AbbVie is seeking a Principal Scientist I in the Tissue Materials Science group to direct research and project activities within the Fillers device franchise (e.g., Juvderm and Next Generation Dermal Fillers). The role involves multi-disciplinary research, regulatory considerations, and cross-functional collaboration to achieve project goals. Responsibilities
Function as a principal investigator/lead, generating original technical ideas and research or development strategies. Represent 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. Authour publications, presentations and/or primary inventor of patents. Serve as a technical advisor and subject matter expert in the discipline. Mentor/train/manage junior staff in a matrix-based organization or as part of a project team. Scientific Execution
Demonstrate creative problem solving and champion new technologies to achieve project goals. Develop and execute 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
Provide technical advisory support 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. Provide regular updates to manager and project teams; contribute and prepare technical reports for the department and management as needed. Cross-Functional Team Representation
Serve as a critical team member in Asset Strategy, developing project strategy and acting as TMS representative on Asset teams, Strategy teams and product development subteams, with expertise in tissue responses to Fillers. Support Design Control activities as the non-clinical representative on development teams with minimal guidance. Organize, schedule, and participate in project team meetings to define and schedule project activities and review progress. Communicate project status to supervisor, project team leader, other research managers, and R&D committees as appropriate. Prepare time and cost estimates of project activities for review by manager to achieve realistic project completion dates. Qualifications
Education and Experience Ph.D. with a minimum of 6+ years of industry experience OR Masters degree with 12+ years of industry experience OR B.S. with 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 (e.g., 21 CFR 820, 21 CFR 210/211, 21 CFR Part 4, Biologics). Experience managing outsourced research activities and in vivo/in vitro research activities. Working knowledge of biocompatibility testing requirements (ISO 10993); experience conducting/managing biocompatibility studies is a plus. Technical report writing proficiency in support of regulatory submissions. Expertise in small/large animal model study performance and imaging. Strong communication, leadership, and multitasking abilities; capable of building relationships with peers and cross-functional partners. Proficiency in mentoring junior staff or serving as a senior technical advisor. The employee must conduct work in compliance with AbbVie and regulatory requirements, including 21 CFR 820, ISO 13485 and ISO 14971. AbbVie internal requirements cover ethics, safety, HR policies, and general business policies. Additional Information
Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico applicants: reasonable accommodations information available via the links in the posting. Compensation ranges and benefits disclosures follow applicable laws and company policies. Note: This job posting reflects the position at the time of posting. Compensation and benefits are subject to change at the sole discretion of the company.
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Principal Research Scientist I, Tissue Material Sciences Fillers
role at BioSpace. AbbVie is seeking a Principal Scientist I in the Tissue Materials Science group to direct research and project activities within the Fillers device franchise (e.g., Juvderm and Next Generation Dermal Fillers). The role involves multi-disciplinary research, regulatory considerations, and cross-functional collaboration to achieve project goals. Responsibilities
Function as a principal investigator/lead, generating original technical ideas and research or development strategies. Represent 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. Authour publications, presentations and/or primary inventor of patents. Serve as a technical advisor and subject matter expert in the discipline. Mentor/train/manage junior staff in a matrix-based organization or as part of a project team. Scientific Execution
Demonstrate creative problem solving and champion new technologies to achieve project goals. Develop and execute 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
Provide technical advisory support 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. Provide regular updates to manager and project teams; contribute and prepare technical reports for the department and management as needed. Cross-Functional Team Representation
Serve as a critical team member in Asset Strategy, developing project strategy and acting as TMS representative on Asset teams, Strategy teams and product development subteams, with expertise in tissue responses to Fillers. Support Design Control activities as the non-clinical representative on development teams with minimal guidance. Organize, schedule, and participate in project team meetings to define and schedule project activities and review progress. Communicate project status to supervisor, project team leader, other research managers, and R&D committees as appropriate. Prepare time and cost estimates of project activities for review by manager to achieve realistic project completion dates. Qualifications
Education and Experience Ph.D. with a minimum of 6+ years of industry experience OR Masters degree with 12+ years of industry experience OR B.S. with 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 (e.g., 21 CFR 820, 21 CFR 210/211, 21 CFR Part 4, Biologics). Experience managing outsourced research activities and in vivo/in vitro research activities. Working knowledge of biocompatibility testing requirements (ISO 10993); experience conducting/managing biocompatibility studies is a plus. Technical report writing proficiency in support of regulatory submissions. Expertise in small/large animal model study performance and imaging. Strong communication, leadership, and multitasking abilities; capable of building relationships with peers and cross-functional partners. Proficiency in mentoring junior staff or serving as a senior technical advisor. The employee must conduct work in compliance with AbbVie and regulatory requirements, including 21 CFR 820, ISO 13485 and ISO 14971. AbbVie internal requirements cover ethics, safety, HR policies, and general business policies. Additional Information
Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico applicants: reasonable accommodations information available via the links in the posting. Compensation ranges and benefits disclosures follow applicable laws and company policies. Note: This job posting reflects the position at the time of posting. Compensation and benefits are subject to change at the sole discretion of the company.
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