Christopher Pombo Email & Phone Number

Use the Quality Event Management (QEM) workflow in TrackWise ETS for the tracking of nonconformance, CAPA, and other quality-related issues.Conduct assignable cause and root cause analyses for CAR-T GMP manufacturing and process investigations using the 5 Whys and Fishbone Diagram.Initiate CAPAs and Corrections to reduce Man/Personnel caused deviations.Provide impact assessments and investigations efficiently to ensure release of patient product by required deadlines.Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits.Maintained 8 Investigations simultaneously in an auditable state.Reprioritize assigned investigations on a constant basis dependent on batch release timeline.Utilized various systems to obtain information for investigations including eLIMS, SAP S4 Hana, SAP Atlas, and Manufacturing Execution System (MES).

Piscataway, New Jersey, United States

• Supervise a team of one Principal Laboratory Technician, four Senior Laboratory Technicians and 10 part time Student Technicians.• Management of cancer cell line expansion, cryopreservation, and distribution for various pharmaceutical clients.• Execute projects for directors and lab managers which include initiation and expansion of LCL, iPSC and cancer cell lines.• Create new protocols for new pilot studies, projects, and clients.• Prepare periodic reports on laboratory projects and services. • Monitor and order liquid nitrogen, gas cylinders, and various reagents for biorepository operations.• Retrieve and prepare stored cell lines for distribution to internal and external investigators.• Created GMP sample handling and distribution protocol.• Operate and train staff on the use of the BioStore III Cryo.• Maintain accurate computer records and perform QA/QC checks as samples are processed.• Maintain and update RUCDRLIMS database, which includes correcting historic data.• Management, expansion, and cryopreservation of CCL-171 cells.

Piscataway, New Jersey, United States

• Promoted due to increased responsibilities for Cancer Cell Line Expansion Projects.• Supervise a team of one Principal Laboratory Technician, four Senior Laboratory Technicians and 10 part time Student Technicians.• Management of cancer cell line expansion, cryopreservation, and distribution for various pharmaceutical clients.• Execute projects for directors and lab managers which include initiation and expansion of LCL, iPSC and cancer cell lines.• Create new protocols for new pilot studies, projects, and clients.• Prepare periodic reports on laboratory projects and services. • Monitor and order liquid nitrogen, gas cylinders, and various reagents for biorepository operations.• Retrieve and prepare stored cell lines for distribution to internal and external investigators.• Created GMP sample handling and distribution protocol.• Operate and train staff on the use of the BioStore III Cryo.• Maintain accurate computer records and perform QA/QC checks as samples are processed.• Maintain and update RUCDRLIMS database, which includes correcting historic data.• Management, expansion, and cryopreservation of CCL-171 cells.

Piscataway Nj

• Supervise, schedule, and train a staff of 4 full time and 13 part time employees.• Manage the initiation, expansion, cryopreservation, and maintenance of CCL-171 cells.• Develop Laboratory Operation and Services SOP's.• Monitor 250 liquid nitrogen tanks and freezers for RUCDR operations.• Prepare periodic reports on laboratory projects and services. • Retrieve and prepare stored cell lines for distribution to internal and external investigators.• Manage the initiation, expansion, cryopreservation, and QA testing of iPSC cell lines.• Responsible for ongoing maintenance of sample database.

Piscataway Nj

• Process biological samples for cell culturing, including whole blood, skin biopsies, lymph nodes, spleens, and leuko-paks• Expand and cryopreserve both internally and externally produced cell cultures, including lymphocytes, PBMCs, fibroblasts, and IPSCs• Quality control of frozen cell cultures, including viability, mycoplasma testing, and DNA extraction• Expand, cryopreserve, and initiate CCL-171 cells used for compromised cell lines• Manage the processing of skin biopsies and the expansion, cryopreservation, QA testing, and troubleshooting of created cell lines.• Compile data for weekly reports for the Fibroblast Team• Train students and interns on sterile technique, lab equipment maintenance, and general fibroblast cell line culturing• Utilize computer tracking software to monitor progress of samples and create locations within controlled temperature units

Wayne Pa

Cherry Hill Nj