Principal Research Scientist I, Tissue Material Sciences Fillers

Role Summary

Principal Research Scientist I, Tissue Material Sciences Fillers. Leads research and project activities within the Tissue Materials Science group, mentoring scientists and driving multi-disciplinary strategies for the Fillers device franchise (including Juvéderm and Next Generation Dermal Fillers). Focus areas include interactions of devices with cells/tissues, device proof of concept, regulatory submission studies (ISO 10993), life cycle compliance, and scientific messaging for advertising/promotional support. Acts as a team leader, engaging stakeholders across global marketing, medical affairs, regulatory, clinical development, and publications.

Responsibilities

• SCIENTIFIC LEADERSHIP
  • 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.
  • Authors publications, presentations and/or primary inventor of patents.
  • Serve as a technical advisor and subject matter expert in the discipline.
  • May mentor/train/manage junior staff in a matrix-based organization or as part of a project team.
• SCIENTIFIC EXECUTION
  • Demonstrate creative 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, threats or business opportunities.
• SCIENTIFIC COMMUNICATION
  • Serve as a technical advisor and subject matter expert to management and internal customers, aligning with cross-functional Asset teams.
  • May contribute to publications, regulatory documents and inventions and present at external conferences.
  • Provide regular updates to management and project teams; prepare technical reports as needed.
• CROSS-FUNCTIONAL TEAM REPRESENTATION
  • Key team member in Asset Strategy, developing project strategy.
  • Represent TMS on Asset/Strategy/product development subteams; provide expertise on tissue responses to Fillers.
  • Support Design Control activities as non-clinical representative with minimal guidance.
  • Organize and participate in project meetings; communicate status to supervisors and R&D committees.
  • Prepare time/cost estimates for project activities to meet realistic completion dates.

Qualifications

• Education: Ph.D. with 6+ years of industry experience, or Master‚Äôs with 12+ years, or Bachelor‚Äôs with 14+ years in a related scientific or engineering discipline (cell biology, molecular biology, pharmacology, immunology, bioengineering, etc.).
• Medical device experience or regulated environment experience preferred.
• Experience in medical device, pharmaceutical, or related R&D settings with a track record of successful projects.
• Working knowledge of medical device, drug and/or biologics regulations (e.g., 21 CFR 820, 210/211, Part 4, Biologics).
• Experience managing outsourced research activities; managing in vivo and in vitro studies.
• Knowledge of biocompatibility testing requirements (ISO 10993); biocompatibility study experience is a plus.
• Technical report writing for regulatory submissions; experience with animal models and imaging.
• Strong communication, leadership, and collaborative skills; ability to multitask and meet deadlines; ability to build cross-functional relationships; mentoring capability.

Skills

• Original technical idea generation and research/development strategy.
• Cross-functional collaboration and project leadership.
• In vitro/in vivo method development; tissue processing; biocompatibility knowledge.
• Technical writing, presentations, and regulatory documentation.
• Mentoring and senior technical advisor capabilities.

Education

• Ph.D. in a related field or equivalent combination of education and experience as detailed above.