Associate Director
Arcellx
Smithsburg, Maryland, United States
Over 11 years of Pharmaceutical Industry experience working with large molecule (VLP and Live-in attenuated vaccines, CAR-T/CAR-NK cell therapy and rAAV gene therapy) and small molecule (ophthalmic sterile liquid and semi-solid only). Motivated team player to lead and support BLA-enabling activities in TAK-003 Dengue Global Phase 3 Clinical Trials (TIDES) best in class preventive vaccine for symptomatic Dengue. Demonstrated strong problem-solving skills in lifting clinical hold on Voyager Therapeutics’ application to begin human clinical trials of its experimental gene therapy VY-HTT01 for rare, neurodegenerative condition Huntington’s disease. Major responsibilities include overseeing Tech Transfer operations, manage manufacturing activities (internal and external) and finalizing contracts, supporting validation activities in both early stage and late-stage product development. Involved with process design optimization through PD lab activities to streamline complex single use aseptic manufacturing operations with cells and proteins, drafting/reviewing of manufacturing batch records (MBRs)/protocols. Managed stability studies under ICH Guidelines to set expiration timeline for DS/DP, Critical Reagents and Diluent. Familiar with LIMS/ Track wise/ EQMS/ LEADS system to manage OOS/OOT, Gap Assessment as part of Tech Transfer, Change Control, authoring IND sections (Batch Analysis,Stability Summary and Conclusion for DP, History of Process Development and Description of Manufacturing Process and Control in DS.
Disclosure information not submitted.
Wednesday, April 26, 2023
10:30 AM – 11:00 AM ET
Wednesday, April 26, 2023
2:00 PM – 3:00 PM ET