Hoa Luu Email & Phone Number

Philadelphia, Pa, Us

Philadelphia, Pennsylvania, United States

Lead ANDA projects with the analytical research and development team from the initiation to submission phase. Serve as project lead providing updates and feedback during project meetings to ensure all deliverables were completed within the required timeframe. Plan, assign and oversee testing activities for method verification, validations, product development, scale-up batches, in-process, release, and stability. Coordinate and collaborate with various departments within the organization… Show more Lead ANDA projects with the analytical research and development team from the initiation to submission phase. Serve as project lead providing updates and feedback during project meetings to ensure all deliverables were completed within the required timeframe. Plan, assign and oversee testing activities for method verification, validations, product development, scale-up batches, in-process, release, and stability. Coordinate and collaborate with various departments within the organization, including product development team for formulation support, technical service team for technical transfer activities, and regulatory affair team for authoring and compiling documents for CMC sections of eCTD filings to support ANDA submissions. Author various technical documents for method development, verification, validation, transfer, and risk assessments. Show less

Philadelphia, Pennsylvania, United States

Evaluate manufacturer technical package and perform literature searches for product information, specifications and testing parameters to determine method verification and validation needs to satisfy industry standard as well as in house requirements. Led and performed verification and validation of analytical test methods for drug substance and finished products following ICH, FDA, and USP requirements. Oversaw testing activities for raw material, product development, in-process, and drug… Show more Evaluate manufacturer technical package and perform literature searches for product information, specifications and testing parameters to determine method verification and validation needs to satisfy industry standard as well as in house requirements. Led and performed verification and validation of analytical test methods for drug substance and finished products following ICH, FDA, and USP requirements. Oversaw testing activities for raw material, product development, in-process, and drug products for various dosage forms, including tablets, capsules, oral suspension, and powder for oral suspension. Conducted experimental analysis, including related substances, assay, blend uniformity, content uniformity, stratified testing, dissolution, and water determination, for product development, in-process, release, and stability. Authored various technical documents for method development, method verification, method validation and risk assessments. Show less

Fort Washington And Lancaster, Pennsylvania

Method development and remediation for analytical procedures including related substances, cleaning and assay for multi-active finished products, in conjunction with consent decree activities. Collaborated and worked closely with receiving laboratories for method transfer activities. Planned work schedule and coordinated with team members for analysis execution. Served as core member of Empower Excellence team charged with harmonizing overall process of acquiring, processing, and documentation… Show more Method development and remediation for analytical procedures including related substances, cleaning and assay for multi-active finished products, in conjunction with consent decree activities. Collaborated and worked closely with receiving laboratories for method transfer activities. Planned work schedule and coordinated with team members for analysis execution. Served as core member of Empower Excellence team charged with harmonizing overall process of acquiring, processing, and documentation of Empower data. Provided departmental trainings for new custom fields created in Empower for control subtraction testing scenario. Audited and approved laboratory notebooks and Empower results to ensure accuracy and completeness. Supported laboratory investigation at internal and external sites. Provided testing support for degradation products, assay, and dissolution for formulation development and marketed product stability samples. Show less

Greater Philadelphia Area

Assisted in development and validation of various test methods, including related substances, assay, and dissolution according to ICH, FDA, and cGMP requirements and guidance for branded, NCE, and generic products, under supervision of senior level chemist. Authored method validation protocols and reports for project development. Conducted CAPA laboratory investigations to identify root causes for atypical laboratory events and non-conformance results. Assisted in designing and testing… Show more Assisted in development and validation of various test methods, including related substances, assay, and dissolution according to ICH, FDA, and cGMP requirements and guidance for branded, NCE, and generic products, under supervision of senior level chemist. Authored method validation protocols and reports for project development. Conducted CAPA laboratory investigations to identify root causes for atypical laboratory events and non-conformance results. Assisted in designing and testing spreadsheets used to import data from Empower for multi-stage dissolutions. Evaluated and validation Empower 2 custom fields and report methods for test types, including related substances, residual solvents, assay, and dissolution. Show less

Greater Philadelphia Area

Analyzed stability samples by utilizing HPLC, UV, Karl Fischer, and dissolution instrumentation for related substances, assay, water determination, and dissolution testing. Performed routine analysis to support formulation development and release of clinical supplies. Organized, compiled, and transcribed stability data into summary sheets and analytical reports in support of expiration dating. Assisted in method development and validation of drug products for related substances and assay test… Show more Analyzed stability samples by utilizing HPLC, UV, Karl Fischer, and dissolution instrumentation for related substances, assay, water determination, and dissolution testing. Performed routine analysis to support formulation development and release of clinical supplies. Organized, compiled, and transcribed stability data into summary sheets and analytical reports in support of expiration dating. Assisted in method development and validation of drug products for related substances and assay test methods. Worked in full compliance with cGMP's regulations. Show less