Natalie Abts

Head of Human Factors Engineering - Device and Packaging Development @Genentech

South San Francisco, CA, US

Lead and mentor a team of human factors engineers, interns, and rotational analystsProvide professional development coaching to team members across device engineering, packaging engineering, project management, and other rolesContribute to strategic decision-marking for a team of 100+ employees in Device and Packaging Development Develop regulatory human factors strategy for protocol review and health authority submissions (e.g, IND, BLA)Conduct outreach activities as member of External Interactions Steering CommitteeCollaborate closely with company stakeholders in Quality, Regulatory, Commercial Labeling, and other areas to facilitate decision-making for Device and Packaging DevelopmentOngoing relationship development with adjacent groups, including early-stage development research and development, personalized healthcare, and Roche Diagnostics to incorporate human factors into product development and clinical trials Oversee interactions with external vendors conducting human factors workCollaborate with Pharmaceutical Development group to identify unique risks with medicinal products and develop novel labeling-based risk mitigation strategies Participate in internal cross-functional patient centricity team, and have organized multiple patient empathy and human factors workshops for internal colleagues to promote patient centricityOversee all human factors work for development of combination products, including new and emerging technologiesReview and approve documentation including usability study protocols, risk analyses, instructions for use, and reportsHave worked with human factors engineers to facilitate multiple product approvals, including an ocular implant system, injectables for both maintenance and emergency use, and a groundbreaking treatment for patients living with food allergies

University of Wisconsin-Madison

MS, Industrial & Systems Engineering, Human Factors and Ergonomics

University of Wisconsin-Madison

BS, Art