Natalie Quan, M.S. Email & Phone Number

• 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… Show more • 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. Show less

• Delivered statistical data analyses and visualizations for FDA and EMA regulatory filings for an enzyme replacement therapy.• Set, tightened, and justified drug substance and drug product specifications by applying industry-standard statistical guidelines.• Applied statistical modeling to determine process capability and product stability.• Provided statistical expertise for method validation acceptance criteria for analytical assay comparison.• Drew data-driven conclusions… Show more • Delivered statistical data analyses and visualizations for FDA and EMA regulatory filings for an enzyme replacement therapy.• Set, tightened, and justified drug substance and drug product specifications by applying industry-standard statistical guidelines.• Applied statistical modeling to determine process capability and product stability.• Provided statistical expertise for method validation acceptance criteria for analytical assay comparison.• Drew data-driven conclusions based on analyses of study results and data trending of clinical batches and manufacturing data.• Conducted exploratory data analysis, create capability histograms, assess specifications, and perform data modeling using JMP software.• Completed JMP course "Statistical Thinking for Industrial Problem Solving" to further develop statistical software skillset.• Researched literature to maintain working knowledge of ICH guidelines, regulatory standards, industry trends.• Collaborated with Quality, Clinical Ops, Tech Ops, and stakeholders on technical strategy for regulatory submissions and responses.• Upheld data integrity by performing data quality checks, routinely updating manufacturing datasets, and verifying data and analyses in collaboration with international CMOs. Show less

• Serve as data analytics software subject matter expert and client liaison (JMP, QbDVision, Prism).• Innovate data management structure to improve data capture, tech transfer processes, and regulatory documentation in cloud-based software for gene therapies in the pipeline.• Support MSAT team with tech transfers by evaluating gene therapy batch records between multiple sites and CMOs.• Trend upstream/downstream/drug product data and create graphs for publication in regulatory… Show more • Serve as data analytics software subject matter expert and client liaison (JMP, QbDVision, Prism).• Innovate data management structure to improve data capture, tech transfer processes, and regulatory documentation in cloud-based software for gene therapies in the pipeline.• Support MSAT team with tech transfers by evaluating gene therapy batch records between multiple sites and CMOs.• Trend upstream/downstream/drug product data and create graphs for publication in regulatory filings for enzyme replacement therapy.• Analyze manufacturing data to identify opportunities for cost savings via increasing product yield.• Collaborate cross-functionally with MSAT, Supply Chain, and Global Regulatory Affairs teams to support data and analysis needs.• Establish data team infrastructure, create project management structure, and manage summer intern. Show less

• Assisted in learning and executing AAV9 downstream platform process to produce gene therapies.• Optimized downstream chromatography and filtration unit operations via DOE studies for an enzyme replacement therapy.• Evaluated novel technologies for next-generation manufacturing processes to improve processing times and product yields (e.g. continuous processing, new resins, TFFs, etc.).• Authored formal reports and memos for studies executed and reviewed process development… Show more • Assisted in learning and executing AAV9 downstream platform process to produce gene therapies.• Optimized downstream chromatography and filtration unit operations via DOE studies for an enzyme replacement therapy.• Evaluated novel technologies for next-generation manufacturing processes to improve processing times and product yields (e.g. continuous processing, new resins, TFFs, etc.).• Authored formal reports and memos for studies executed and reviewed process development reports.• Purified HEK-293 harvest material produced from upstream cell culture team to assess product quality.• Maintained vendor relations and collaborated with Science R&D teams.• Tech-transferred multiple projects between CMOs around the country and internationally.• Trained new employees and graduate co-op students. Show less

Greater New York City Area

•Rotated through the Downstream Purification, Upstream Cell Culture, and Analytical Science departments over the course of six months to gain a holistic understanding of the process development of a therapeutic protein.•Worked towards completing a final project in which the entire process from bioreactor set-up through protein purification and validation assays will be performed for a temperature-shift experiment. •Downstream Purification – Assisted in executing multiple lab-scale AEX… Show more •Rotated through the Downstream Purification, Upstream Cell Culture, and Analytical Science departments over the course of six months to gain a holistic understanding of the process development of a therapeutic protein.•Worked towards completing a final project in which the entire process from bioreactor set-up through protein purification and validation assays will be performed for a temperature-shift experiment. •Downstream Purification – Assisted in executing multiple lab-scale AEX chromatography and IMAC experiments utilizing AKTA instruments. Packed XK16/20, HiScale 16/20, and HiScale 16/40 columns. Performed asymmetry tests to assess column characteristics. Independently executed a continuous direct product capture experiment utilizing two columns over a five day period. Prepared all buffers necessary for the experiments. •Upstream Cell Culture – Gained hands-on experience with mammalian cell culture utilizing aseptic technique. Completed seed train expansion using Vi-CELL Analyzer in preparation for bioreactor inoculation. Worked in a team of three to set up two 3L bioreactors. Plan to monitor and maintain bioreactors for 21 days using Finesse Bioreactor Controllers and DeltaV DCS System. •Analytical Science – Trained to perform an ELISA used to assess the enzyme activity of therapeutic protein samples. Analyzed the results utilizing SpectraMax microplate reader. Assisted in HPLC experiments to assess sialic acid content using Vanquish Horizon System and Chromeleon Software. •Maintain electronic lab notebook with proper documentation for all experiments performed. Show less

Greater Chicago Area

• Directly supported PI with proprietary research investigating radiation effects on the ovarian microenvironment via two projects that each led to first-author publications: 1) Differential strain-dependent radio resistance modeling off-target effects of radiation. 2) Analysis of human ovarian follicle dynamics.• Performed in-depth statistical analysis using Graphpad Prism Software.• Awarded “Best Presentation” on presentation and poster of research in a group of 10+ students… Show more • Directly supported PI with proprietary research investigating radiation effects on the ovarian microenvironment via two projects that each led to first-author publications: 1) Differential strain-dependent radio resistance modeling off-target effects of radiation. 2) Analysis of human ovarian follicle dynamics.• Performed in-depth statistical analysis using Graphpad Prism Software.• Awarded “Best Presentation” on presentation and poster of research in a group of 10+ students at the 2017 Master’s of Biotechnology Industrial Advisory Board Meeting • Served as an ad-hoc journal reviewer for Journal of Adolescent and Young Adult Oncology.• Offered full-time position as laboratory technician post-graduation. Show less

Greater New York City Area

Collected clinical data and performed analyses investigating the effects of inhaled antibiotics on ventilator associated tracheobronchitis in children with tracheostomies. Shadowed pediatric pulmonologists performing bronchoscopies and treating cystic fibrosis and asthmatic patients for routine visits. Composed an IRB protocol for a retrospective chart review.

Raleigh-Durham, North Carolina Area

Independent Study Student: Designed an experimental paradigm and coding scheme investigating the 18-month-old infants’ language development abilities in response to gestures, especially pointing. Analyze collected data of longitudinal study investigating motivation underlying infants’ pointing gestures.Research Assistant: Recruited and tested four-month-old to five-year-old human subjects. Coded looking time, transcribed videos, and administered standardized language measures for… Show more Independent Study Student: Designed an experimental paradigm and coding scheme investigating the 18-month-old infants’ language development abilities in response to gestures, especially pointing. Analyze collected data of longitudinal study investigating motivation underlying infants’ pointing gestures.Research Assistant: Recruited and tested four-month-old to five-year-old human subjects. Coded looking time, transcribed videos, and administered standardized language measures for multiple studies investigating infant development. Show less

Raleigh-Durham, North Carolina Area

Vertical Integration Program Summer Research Intern: Researched in the Wilbourn Infant Laboratory at Duke University. Completed data collection and analyses for a study investigating infants’ communicative behaviors. Mentored and trained research assistants. Composed a 50-page laboratory procedures manual. Attended weekly talks by invited speakers well known in the field and statistic workshops (twice weekly).

Raleigh-Durham, North Carolina Area

Water Safety Instructor: Completed a 30-hour training to become an American Red Cross certified Water Safety Instructor. Taught private and group swim lessons to 12-month-old to 35-year-old students.Lifeguard: Completed a 30-hour training to become an American Red Cross certified Lifeguard. Renewed my CPR certification annually and Lifeguard certification biannually. Authorized operator of Automated External Defibrillator (AED) and Pediatric and Adult CPR Certified. Ensured the safety… Show more Water Safety Instructor: Completed a 30-hour training to become an American Red Cross certified Water Safety Instructor. Taught private and group swim lessons to 12-month-old to 35-year-old students.Lifeguard: Completed a 30-hour training to become an American Red Cross certified Lifeguard. Renewed my CPR certification annually and Lifeguard certification biannually. Authorized operator of Automated External Defibrillator (AED) and Pediatric and Adult CPR Certified. Ensured the safety of facility patrons by recognizing and responding effectively to immediate emergencies. Show less

Bachelor’S Degree, Biology/Biological Sciences, General

Activities and Societies: alpha Kappa Delta Phi, Duke University Aquatics, Duke University Hospital Pediatric Bone and Marrow Transplant.

Master’S Degree, Biotechnology

Activities and Societies: Association of Biotechnology Students