Assunta Ng Email & Phone Number

Senior Research Chemist with expertise in analytical pharmaceutical analysis, protein aggregation, residuals, and preservatives. Experience includes project coordination, supervising and training. Reputation for excellence in problem solving, method development and new technology. Appreciated for prompt delivery of results and creating positive learning environment.

Subject matter expert for aggregation and fragmentation assays for all protein, vaccine and antibody projects. Trouble shooting for Process and Manufacturing groups using analytical assays. Developed assays for HPSEC-UV-MALS-FL, high throughput assays, MacroIMS, DLS, HPLC, HIC, preservatives, and detergents. Coordinated testing for various projects. Trained and supervised junior staff. Performed cGMP audit on electronic laboratory notebooks. Trained and coordinate testing for various outsource companies.• Prompt method development of protein aggregation assays, which enabled process and formulation groups to make FDA approved products.• Coordinated testing for Gardasil vaccine, which led to prompt product launch and qualification of new manufacturing facilities.

Subject matter expert for aggregation and fragmentation assays for all protein, vaccine and antibody projects. Trouble shooting for Process and Manufacturing groups using analytical assays. Developed assays for HPSEC-UV-MALS-FL, high throughput assays, MacroIMS, DLS, HPLC, HIC, preservatives, and detergents. Coordinated testing for various projects. Trained and supervised junior staff. Performed cGMP audit on electronic laboratory notebooks. Trained and coordinate testing for various outsource companies.Prompt method development of protein aggregation assays, which enabled process and formulation groups to make FDA approved products.Coordinated testing for Gardasil vaccine, which led to prompt product launch and qualification of new manufacturing facilities.Automated HPLC testing for more than ten antibody projects, which reduced results turnaround time three-fold.Research BiochemistDeveloped analytical methods for protein, vaccines and monoclonal antibody products, their excipients, preservatives, detergents, and residuals. Coordinated stability studies, assay transfer to outsource company, and move to new facilities. Use of various automated assays to study enzyme kinetics to characterize products.Developed new preservatives formulation for multivalent vaccine products and new analytical assay to test multiple preservatives, which lead to patent filing and approval in US and EU.Created audit map for analytical testing, which helped efficient HPV regulatory filing.Prompt coordination of outsourcing of RNA, total carbohydrate and lipids assays to Lancaster Labs, which facilitated product approval.

Master'S Degree, Analytical Chemistry

B.S, Chemistry

Professional Development Various leadership and supervising trainings. Project Management trainings. cGMP trainings, including Second.

Master'S Degree, Biological Chemistry

Activities and Societies: Chinese student association member and treasurer.