James Grimaldi Email & Phone Number

Cambridge, Ma, Us

- Executed process characterization protocol for company’s leading drug candidate in preparation of Phase 3 clinical trials, wrote documentation to support activities (batch records, SDMQ protocol)- Routinely conducted and analyzed data from fermentations (2.5 L scale) for process characterization to evaluate how raw material lots and process parameter variations impact drug substance CQAs· Detailed experience with upstream processing of microbial cultures – bioreactor assembly, media preparation, inoculation, sampling, culture harvest and concentration, formulation and lyophilization- Conducted downstream processing of microbial EVs (depth filtration, TFF) to support CMO drug substance manufacturing decisions – compared raw material lots, investigated filter alternatives- Communicated experimental designs at internal team discussions for experiment planning, presented experimental results at Technical Operations leadership meetings to facilitate key business decisions- Trained new employees on lab equipment and transferred knowledge of drug substance production

Cambridge, Ma, Us

- Routinely designed, conducted, and analyzed data from microtiter plate experiments with anaerobic bacteria to support CMO drug substance manufacturing decisions and answer key process questions- Compared different raw material lots, tested alternative media preparation methods, and varied critical process parameters to determine process robustness and effect on microbe growth and metabolism- Investigated the differences between two related processes at the 12 L bioreactor scale and evaluated the effects on resulting drug substance in order to influence key business decisions for clinical trials- Acquired benchtop skills (microscopy, Gram staining, pipetting, solution preparation, autoclaving) and performed general laboratory maintenance (equipment upkeep, waste disposal, cleaning, restocking)