Natalie Quan

About Natalie Quan

Natalie is currently a Product Manager at QbDVision. She has previous technical experience in CMC Regulatory, Technical Operations, and Process Development. Her skillset includes providing statistical analysis and data management support for regulatory submissions to the FDA and EMA. She applies her technical knowledge of drug development processes for biologics and AAV gene therapies to meaningfully interpret data. She gained this knowledge while starting her career at Amicus Therapeutics.Natalie graduated from Northwestern University with a M.S. degree in Biotechnology and graduated from Duke University with a B.S. degree in Biology and minors in Psychology and Spanish. She is invested in patient-oriented healthcare opportunities in the biotechnology and pharmaceutical industries. Her goal is to expand her knowledge base and further develop her technical skillset. She is a passionate contributor and is invested in creating meaningful impact through her work!Key Skills:• Making data-driven decisions• Statistically analyzing data and reporting key metrics through visualizations• Specification tightening, shelf-life stability estimations, and acceptance criteria evaluations• Maintaining working knowledge of pharmaceutical regulations (FDA, EMA, ICH, etc.)• Optimizing downstream biologics and gene therapy processes• Collaborating with CMC Regulatory, Global Regulatory Affairs, Technical Operations, Clinical, and R&D teams• Effective communicator and team player• Self-motivator and life-long learner

Experience

1. Product Manager

   Qbdvision

   Aug 2022 — Present

   Develop user stories, requirements, and acceptance criteria for new features and improvements that represent customer and market needs for implementation of a digital CMC strategy.• Advance the biotechnology and pharmaceutical industries by developing a centralized CMC platform based on the Quality-by-Design (QbD) approach.• Leverage biotechnology industry knowledge and previous experience as a user persona to impact users and ultimately, patients.• Synthesize accurate user requirements via collaborations with user personas from large pharmaceutical companies, biotechnology startups, and CDMOs for biologics and small molecule applications. • Deepen industry knowledge of product and process lifecycle management requirements including regulatory trends, expectations, and challenges through literature research, webinars, and forums.• Conceptualize, prioritize, and deliver new features in product triad with Engineering and UX/UI Design.• Manage software release activities and readiness with webinars, training, and documentation.• Conduct product discovery through user interviews surveys, competitor research, and usage data.• Coordinate development work and participate in Agile sprint planning, grooming, and retrospectives.• Manage a prioritized backlog that balances user experience with business goals and technical debt.• Work cross-functionally with Sales and Marketing teams on go-to-market and sales enablement activities.

Education

• Duke University

  Bachelor’s Degree

• Northwestern University

  Master’s Degree

Skills

• Microsoft Office
• Microsoft Excel
• Microsoft Word
• Leadership
• Powerpoint
• Research
• Public Speaking
• Community Service
• Event Planning
• Teamwork
• Communication
• Biological Data Analysis
• Patient Care
• Tutoring
• Laboratory Skills
• Biotechnology