John Cargo Iii Email and Phone Number

• Coordinate and perform cGMP manufacturing operations for manufactured products using the unicorn software the AKTA Ready and XL, Pall UF/DF skid, also different pod filter and cassette apparatuses per government mandated regulatory guidelines and OSHA safety requirements.• Supervise the effective use of client materials, equipment and personnel while making products at high quality levels per Management set objectives.• Perform for real-time batch record/logbook review to ensure ‘right first time’ execution.• Execute manufacturing processes without supervision and provide work direction and guidance to less experienced personnel.• Act as shift lead, authoring shift notes, and conducting shift exchange/ and process execution step hand-offs.• Troubleshoot and maintain manufacturing equipment.

• Performed and lead daily Cell Culture manufacturing operations from Aseptic Vial Thaw to the 2000L Bioreactor in a cGMP environment.• Operated all process equipment, following SOPs, and analyze in-process samples. • Conducted monthly and quarterly area and equipment safety inspections for the Small Scale area.• Documented all data and information in Batch Production Records, Solution Lot Records and equipment logbooks in a cGMP compliant fashion.• Assisted in the execution of validation protocols and EM sampling.

• Peform execution of pilot-scale cGMP operations for Tox study and clinical trial manufacturing of novel vaccine drug substance • Conduct upstream processes and perform in-process analytical testing • Coordinate projects with TD process sciences and TD analytical for knowledge sharing, collaboration, and tech transfer activities • Operate and utilize online databases including, LIMs sample management, SAP, PI Data Historian, Maximo work order tracking, Unicorn, and Atlas controlled document management

• Performed purification, sterile filtration, and final fill operations for client products derived from bulk cell culture harvest material in ISO 7 class 10,000 cleanrooms. • Operated AKTAprocess, chromatography columns, tangential-flow filtration devices, and biosafety cabinets. • Executed engineering runs and validation protocols for new equipment and procedures.• Trained 5 other employees in buffer prep, column cleaning and use, and skid operation.• Followed all batch records, SOP’s, SMP’s, and safety guidelines to stay in compliance with cGMP regulations.

• Support transfer of analytical methods and SOP’s from third party to the Quality Control Laboratory.• Assess the product quality of protein biologics generated in MS&T Upstream and Downstream groups or third party using UV280 analysis, and HPLC techniques including Hydrophobic Interaction, Size Exclusion, Affinity, and Reverse-Phase.• Perform assay troubleshooting and method development as needed.• Train others on new methods as an SME.• Function in a GMP environment to bridge the gap between development and Quality Control.

Sustained cell culture lines in order to produce media with proteins to be purified for vaccine use.Isolated protein using affinity purification, gel filtration, and enzyme digestion.Evaluated protein expression levels using conventional and Native-gel Western Blot analysis.Performed DNA amplification using PCR sequencing, DNA transformation, and cell transfection. Performed cell culture with multiple mammalian lines.

• Carried out the method development for the P. Vivax malaria protein vaccine isolation project.• Supported Lab-scale to Bulk production using Affinity, and Ion Exchange Chromatography methods using the Akta Prime instrument, also5L Bioreactor Fermentation, SDS-PAGE, Immunoblot, Limulus Amebocyte Lysate assay, ELISA, and Intracellular Cytokine Staining..• Conducted mouse studies, performing injections, surgeries, tagging, sacrifices, tissue and blood collection, and any other animal handling and care.• Perform all lab analysis and documentation per GLP standards.