Allen Chu Email & Phone Number

New York, Ny, Us

Boston, Massachusetts, Us

• Prepare and review CTD for BLA/NDA, with a focus on global manufacturing and analytical standards, ensuring full regulatory compliance• Partner with the China and Japan regulatory teams to expedite the preparation of essential documents for BLA/NDA filing and coordinated materials for contract lab/ import testing• Prepare and verify CMC document such as description of drug product, release specification, test methods and validation, and stability summaries and data• Review analytical testing methods against global standards (USP, Eur. Ph, JP, and ChP), identifying discrepancies and ensuring adherence to international pharmacopeia guidelines• Perform period review to ensure analytical method and validation are compliance with oncoming ICH Q2(R2) and follow ICH Q14 to harmonize analytical method development

Boston, Massachusetts, Us

• Developed and executed strategies and timelines for the validation and transfer of analytical methods, enhancing support for both commercial and clinical programs• Develop and optimize analytical LC methods (SEC, PS80 and Titer), plate-based assays (ELISA, Potency, complement binding, enzymatic activity, residual impurity assays), electrophoresis assays (SDS-PAGE, IEF and iCE) to support clinical and commercial program• Provide key input to gap assessment/remediation with internal and external QC labs, overseeing method procedures and validation/transfer outcomes to boost project efficiency • Lead the method transfer/validation activities with internal and external QC labs and develop the corresponding dashboard for enhanced tracking and accountability• Work with cross-functional teams to provide continuous technical support in troubleshooting and OOS/OOT investigation• Acted as a key representative for departmental functions in audits, addressing queries from both external and internal reviewers, and crafting technical responses to Health Authorities' inquiries

Boston, Massachusetts, Us

• Identify and implement best practices and systems to maintain GMP compliance across areas of responsibility with regards to current procedures, policies and training across areas of responsibility• Perform method validation and DS/DP release and stability testing for clinical QC• Maintain up-to-date knowledge of pharmaceutical industry regulations in USA, EU and JP• Assess and manage appropriate project risks and develop control strategies• Train, coach, and mentor new hires and develop training materials (onboarding package) for the team• Coordinate and maintain sample management system and inventory to ensure sufficient materials supply

Tarrytown, New York, Us

Conduct qualification and validation testing for release, stability and in-process productsAnalyze data with LIMS, JMP, and Excel to facilitate assay transfer internally and externallyProvide analytical support for troubleshooting and conduct investigation of commercial product complaint by performing FT-IR analysisEnter and monitor results a laboratory information management system (LIMS), investigating and reporting atypical results or trends as necessary.Perform, write, revise and review standard operating procedures (SOPs).Interpret and apply cGMPs, USP, regulatory requirements and industry best practices

New York, Ny, Us

Optimization & Formulation ProcessOptimized the new micelle formation mechanism in order to minimize the interfacial tension during the transportation of crude oilConducted Quality Control of the polymer solution, performed Continuous Improvement to design the numerical modelsStatistical analysisUtilized UV-Vis and DLS to analyze the dynamic properties of polymer solutionsPerformed numerical analysis by ChemDraw, Matlab, and KaleidaGraph to investigate the physical and geometrical properties of surfactants

北京, Beijing, Cn

Organic Synthesis • Specialized in hydrogel synthesis as well as organic synthesis techniques• Gained in depth knowledge in hydrogel technology and drug delivery for pharmaceutical application• Presented the collection, analysis and review of experimental data by Matlab and Excel for publication and presentation • Maintained daily operation such as lab inventory management, instruments maintenance and Meeting the lab safety standards

Tw

Manufacturing Experience• Supported and developed novel Dengue vaccine in vaccine manufacturing plant • Developed and characterized a new microenvironment for HSCs to expand in vitroStem Cell Research• Demonstrated expertise in stem cells culture and umbilical cord blood purification• Applied Fluorescence Activated Cell Sorters as well as real-time PCR to investigate the self-renewal process of hematopoietic stem cell in vitro. • Collaborated with doctoral candidates and postdoctoral associates and reported our progress twice a week Hematopoietic stem cells are very rare and multipotent in human body. However, the expansion of HSC in vitro is difficult to achieve because the cells tend to differentiate and loss the ability of self-renewal. Our team created a model to mimic the microenvironment in human bone marrow with Mesenchymal stromal cells as a cell-to-cell contact physical boundary and different growth factors.

Mba, Business Administration And Management, General

Master'S Degree, Healthcare Leadership

Master’S Degree, Chemical And Biomolecular Engineering

Bachelor'S Degree, Chemical Engineering