Stephen Moran Email & Phone Number

Palo Alto, Ca, Us

• Lead process development and manufacturing of cell therapeutics in a cGMP environment for Phase I/II cancer clinical trials at the Laboratory of Cell and Gene Medicine (LCGM)• lead in execution of various CAR-T clinical biomanufacturing campaigns as an Operator and Verifier• Development of Master Cell Banks to help build the pipeline for Vector production at LCGM• Coordination of campaign activities with CMC operations, Quality Assurance, Quality Control, and Operations• Identify strategies for innovation in production systems and manufacturing processes • Determinations of deviations, revision of batch records, formulation of process development SOPs, work instructions, and tech transfers • Utilization of cell processing platforms (LOVO, ClinMACS prodigy, Controlled Rate Freezer, Cellometer Auto 2000)• Execution of in-house comparability studies, third-party comparability studies, and vector comparability studies for Process Development and Manufacturing. • Member of ISCT with the completion of workforce development in biomanufacturing program, CITI, EPIC, Medrio, and HIPPA compliant• Maintains compliance with own training and trains junior staff upon completion of qualification

Ingelheim Am Rhein, Rhineland-Palatinate, De

Manufacturing Associate (September 2021 - April 2022)Execution of purification of manual and automated operations including Chromatography, Viral Filtration, Tangential flow filtration, Bulk filtration, and BDS freezing. Execution of SoloVPE using A280 and A310 for protein concentration determination Execution of viral inactivation with acid and base titration Working with management, supervisors, and process engineers in process development for bulk manufacturing Manufacturing Technician Downstream Purification (August 2020 - September 2021)Qualified in the execution of CIP/SIP of tanks, transfer lines, portable tanks, and chromatography skids wash Qualified in buffer preparation with transfer to hold tanks and disposables In process sampling of pH and conductivity and routine sampling Execution of electronic batch records in manufacturing execution system (BioMES), process control systems (DeltaV) and utilization of OPSlims. Perform internal support duties including stocking, consumables/materials Documentation of work according to cGMP and cGDP Adheres to established regulations and follows cGMP by site and read and understand SOPs Maintainer of production area according to predefined standards (5s) Maintainer of own training within compliance and trainer other peers on operations upon completion of qualification Notable Projects and affiliations:Column Packing slowdown project to develop and execute presentations for QC, Management, and Manufacturing on column packing processing. Qualified SME for BioMES 7.2 instructor. Member of ARE team to work closely with peers to establish 5s and ARE standards for downstream operations and stagging.

San Francisco, California, Us

Seattle, Washington, Us

Bachelor Of Arts - Ba, Biology, General

Associate Of Science - As, Biology: Medical

Associate Of Arts And Sciences (A.A.S.), Natural Sciences With Emphasis In Biological Sciences