Lisa King
Nonclinical Study Manager @ Astellas Pharma
About
I am a Nonclinical Operations Manager with 10 years experience outsourcing and managing nonclinical studies with Contract Research Organizations in the gene therapy and AAV field.
United States
San Francisco Bay Area
Biotechnology
Gene Therapy, AAV research, Good Laboratory Practice (GLP)-trained, Molecular Biology, Assay Development, Real-Time Polymerase Chain Reaction (qPCR), Polymerase Chain Reaction (PCR), Cell Culture, Cell Biology, Biotechnology, Life Sciences, Pharmaceutical Industry, Cell, GMP, Lifesciences
Experience

Manager, Nonclinical Operations
Richmond, CA
• Selected, contracted, monitored and managed 15 key early development non-GLP nonclinical pharmacology and toxicology studies with Contract Research Organizations (CROs). • Prepared and coordinated review of study protocols, reports and other documents to ensure accuracy and timely completion of nonclinical studies. • Monitored study progress to ensure that study activities are consistent with the protocol and with the needs of the project. • Supervised the trafficking of study samples, data, and study documents between Sangamo, Contract Research Organization (CRO), or other outside collaborator. • Maintained records to ensure accurate sample inventory and traceability. • Trained in conducting GLP studies in compliance with current regulatory requirements. • Conducted and oversaw external of CRO facilities. • Maintained understanding and awareness of general in vivo AAV and gene therapy pharmacology and toxicology best practices • Adhered to good documentation practices; departmental procedures and safety requirements. • Represented the department by participating on project teams.

Senior Research Associate, Nonclinical Operations
•Selected, contracted, monitored and managed 25 early research non-GLP nonclinical pharmacology and toxicology studies with Contract Research Organizations (CROs) • Prepared and/or coordinate review of study protocols, study reports and other study documents to ensure accuracy and timely completion of nonclinical studies. • Monitored study progress to ensure that study activities were consistent with the protocol and with the needs of the project. • Supervised the trafficking of study samples, data, and study documents between Sangamo, Contract Research Organization (CRO), or other outside collaborator. • Maintained records to ensure accurate sample inventory and traceability. • Trained in conducting GLP studies in compliance with current regulatory requirements. • Conducted and/or oversaw external CRO facilities. • Maintained understanding and awareness of general in vivo AAV and gene therapy pharmacology and toxicology best practices • Adhered to good documentation practices; departmental procedures and safety requirements. • Represented the department by participating on project teams.

Research Associate IV, Nonclinical Operations
•Selected, contracted, monitored and managed 75 early research non-GLP nonclinical pharmacology and toxicology studies with Contract Research Organizations (CROs) • Prepared and/or coordinate review of study protocols, study reports and other study documents to ensure accuracy and timely completion of nonclinical studies. • Monitored study progress to ensure that study activities were consistent with the protocol and with the needs of the project. • Supervised the trafficking of study samples, data, and study documents between Sangamo, Contract Research Organization (CRO), or other outside collaborator. • Maintained records to ensure accurate sample inventory and traceability. • Trained in conducting GLP studies in compliance with current regulatory requirements. • Conducted and/or oversaw external CRO facilities. • Maintained understanding and awareness of general in vivo AAV and gene therapy pharmacology and toxicology best practices • Adhered to good documentation practices; departmental procedures and safety requirements. • Represented the department by participating on project teams.

Research Associate III, Nonclinical Operations
•Selected, contracted, monitored and managed 25 early research non-GLP nonclinical pharmacology and toxicology studies with Contract Research Organizations (CROs) • Prepared and/or coordinate review of study protocols, study reports and other study documents to ensure accuracy and timely completion of nonclinical studies. • Monitored study progress to ensure that study activities were consistent with the protocol and with the needs of the project. • Supervised the trafficking of study samples, data, and study documents between Sangamo, Contract Research Organization (CRO), or other outside collaborator. • Maintained records to ensure accurate sample inventory and traceability. • Trained in conducting GLP studies in compliance with current regulatory requirements. • Conducted and/or oversaw external CRO facilities. • Maintained understanding and awareness of general in vivo AAV and gene therapy pharmacology and toxicology best practices • Adhered to good documentation practices; departmental procedures and safety requirements. • Represented the department by participating on project teams.

Research Associate III, Assay Development
•Developed molecular biology-based assays using Zinc Finger technology for genomic medicines •Supported clinical assays for the Phase 1/2 HIV clinical study using zinc finger nucleases (ZFNs) to disable the CCR5 gene in T lymphocytes and hematopoietic stem and progenitor cells (HSPCs), including Cel-1 nuclease, RT-qPCR-based, and flow cytometry. •Supported assays for the Phase 1/2 beta thalassemia clinical study using ZFNs to disable the BCL11A enhancer gene in HSPCs, including Western, peripheral cell and DNA isolation. •Developed ELISA-based AAV-specific assays for the Phase 1/2 Hemophilia A (Factor VIII) clinical study using recombinant AAV vector encoding a modified Factor 8 cDNA
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