Experience

MacroGenics, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Validation Specialist

  • Sep 2022 - Present

  Rockville, Maryland, United States *Review Computer System Validation documents *Author Validation Master Plan for site relocation projects *Assist and provide validation expertise to various functional groups in relocating temperature units and analytical equipment *Continuously improve and strengthen validation department *Continuously support commissioning, SAT, FAT, IQ/OQ/PQ activities, and manage site projects

• Validation Specialist III

  • Aug 2020 - Sep 2022

  Rockville, Maryland, United States Provide QC expertise in reviewing analytical method validation protocols. Write IOQ/PQ protocols for utilities and GMP/GLP equipments. Write URS, Risk Assessments and Verification Plans for QC, Manufacturing and GLP equipments and systems.

• Validation Specialist II

  • Mar 2018 - Aug 2020

  Washington D.C. Metro Area Prepare and perform IOQ protocols for equipments, And systems to ensure compliance within GMP and GLP validation regulations. Perform validation on CTUs, process equipments, and utilities. Maintain and improve a robust validation program Compare and analyze validation data, prepare reports and make recommendations for changes/improvements. Ensure a risk based approach to qualification and validation to optimize system testing efforts is applied. Review… Show more Prepare and perform IOQ protocols for equipments, And systems to ensure compliance within GMP and GLP validation regulations. Perform validation on CTUs, process equipments, and utilities. Maintain and improve a robust validation program Compare and analyze validation data, prepare reports and make recommendations for changes/improvements. Ensure a risk based approach to qualification and validation to optimize system testing efforts is applied. Review IOQ protocols for in-use equipments, systems and processes.



AstraZeneca/MedImmune/Leidos Biomedical/Qiagen Sciences/Lonza

• Biotech Professional

  • Sep 2006 - Mar 2018

  Frederick, MD • Providing robust process flows, knowledge and full understanding of material to Quality Control testing groups and manufacturing. • Key liaison in initiating deviations and Out of Specification reports in Trackwise system. Assure Corrective and Preventive Actions are implemented. • Applying critical thinking to solve complex problems with the team that may unexpectedly arise. • Participate in external customers, ISO and FDA audits on a routine basis by fulfilling auditors’… Show more • Providing robust process flows, knowledge and full understanding of material to Quality Control testing groups and manufacturing. • Key liaison in initiating deviations and Out of Specification reports in Trackwise system. Assure Corrective and Preventive Actions are implemented. • Applying critical thinking to solve complex problems with the team that may unexpectedly arise. • Participate in external customers, ISO and FDA audits on a routine basis by fulfilling auditors’ requests. • Analyze and trend Environmental Monitoring and Utilities data quarterly • Investigate excursions and deviations when required during weekly Environmental Monitoring of production suites. • Proficient in Microbiological and Cell Culture assays adhering to Standard Operating Procedures. • Pull Stability samples on a day-to-day to basis or as per the Stability schedule and the stability study protocols. • Staged incoming or aliquoted Drug Product or Drug Substance samples at various conditions to be pulled later at designated time . • Perform bioburden assay on utility and in-process samples. Manage data in Sapphire LIMS database. • Propagate K562 and HeLa Cell Cultures for various assays: Initiate, feed, subculture/splitting of cell culture performed regularly. • Perform LAL/Endotoxin assay on routine USP water and buffers. • Coordinated cell culture and plasmid sample activities with other labs in a timely manner. • Effectively communicating test results, excursions or lab issues with management and QC team. • Be extremely organized and alert to perform all scheduled activities for the day and week to ensure that the work is completed in a timely manner. • Initiated and managed deviations and OOS reports when required • Validation protocols (IQ, OQ) written and performed on Spectramax units. • Perform Gram Stain and Biochemicals on bacterial isolates. • Subculture bacterial and fungal cells to TSA and SDA plates, respectively. Show less