James Lowe Email & Phone Number

Cambridge, MA, US

Cambridge, Massachusetts, United States

• Driving in-process data analysis for VCAR33 and Trem-cel manufacturing historical data trending (JMP)
• Built shift scheduling platform for cross-functional operations from donor to patient
• Creating metrics dashboard to visualize & track cleanroom operations, including reviewing and tracking of equipment records for PM/calibration, cleanroom cleaning and maintenance
• Operating/Verifying in VCAR33 clinical manufacturing processes involving CAR-T therapies (CD33+) targeting leukemic cells in refractory Acute Myeloid Leukemia (AML) patients
• Operated in Trem-cel gene-therapy manufacturing of allogeneic eHSC transplants for patients with AML to protect them from CD33+ targeting therapies
• Created Trem-Cel Manufacturing Overview presentation and routinely train new personnel

• Pursuing directed research in the Biochemistry and Proteomics Laboratories with Darie's Research Group (DRG) to assist in the proteomic analysis of human breast milk using mass spectroscopy to reveal protein biomarkers.
• Performed directed research in polymer chemistry. Worked in Lu's Research Group (LRG) to synthesize a new color-changing polymer that is activated by stress
• Manipulated ordinary differential equations such as the Runge-Kutta and Euler methods in MATLAB to apply to biotechnology, relating to the action potential of the heart

Potsdam, NY

• Led a group of six chemical engineering students to design a chemical production plant for the manufacturing of 1,3-Butadiene from Bioethanol produced by Lignocellulosic Biomass
• Evaluated design parameters and economic viability for production using Process Simulation Software and Economics

Andover, Massachusetts, United States

• Led 3 M1 investigations in Quality (Quality Assurance Reports) and Safety (Medgates) using DMAIC principles to establish Root Cause, Corrective Actions, and Preventive Actions (CAPAs) through Trackwise QTS and Veeva.
• Trended key process parameters using SCADA Monitoring and Control system and analyzed data to provide impact statements on equipment performance for quality assurance investigations
• Optimized Final Fill parameters for a Polysaccharide (Prevnar-13) production batch based on historical variability and communicated new processing targets to shift management to align with customer specifications
• Authored cGMP documentation (SOPs, MBRs, & TRNs) across the site
• Led Cross-functional Continuous Improvement Projects
• Led daily meetings tracking CAPAs and Quality Investigations

St Albans, Vermont, United States

• Managed lifeguard staff and inventory
• Maintained pool water chemistry and filtration systems for an aquatics center
• Led and oversaw a group of 10 employees per shift
• Instructed Red Cross Water Safety Instruction Levels 1-6
• Exemplified strong communication and customer service skills