➢As the resident subject matter expert (SME), I spearheaded the optimization and development of a fit-for-purpose viability assay for a 3D hydrogel-based construct, across a variety of analysis methods (indirect, direct, enzymatic, functional, kinetic, and endpoint), and performed 19+ studies to optimize each step of the assay in only 4 months.➢Improve the construct generation process by developing and authoring SOPs for 6+ methods, designed and validated in collaboration with 2+ teams, to enable in vitro compatibility, less construct loss to QC, and a process that is 1.5x quicker and more consistent than a hybrid-bioprinting process.➢Improved the simplicity and consistency of cell culture processes by designing and fabricating 13+ unique tools.➢Worked as part of a team to perform a gap analysis, and source all the components to re-initiate an autologous cell therapy manufacturing process that was paused 15 years ago, assuming the role of the in-house SME, with the goal of initiating tech transfer to a CDMO. This includes spinning up CMC capabilities in a non-GMP facility to enable a path to commercialization, re-initializing the workflows to manufacture patient cells in a closed cell culture system, identifying viable replacement options for discontinued reagents and consumables, and acquiring new instrumentation.➢Collaborated with 15+ vendors to identify and source 200+ off-the-shelf and custom-made components.

Freelance SME to train 4+ AI chat assistants to teach STEM topics at a high school through college level.

➢Worked independently as part of a team on 9+ projects, resulting in 5 peer-reviewed journal articles, 2 articles in submission or final preparation, 8 external presentations, 5 fellowships or awards, and 2 patents. A comprehensive list can be found on LinkedIn. (www.linkedin.com/in/zachary-sitte)➢Utilized primary cells and 15+ immortalized cell lines from 6+ tissue origins, in mono- and co-culture configurations, in 2D and 3D culture environments, to study drug-resistance and progression in cancer.➢Utilized and optimized a variety of molecular biology techniques (e.g., flow cytometry, western blot, and ELISA) and function assays (cytotoxicity, cell cycle, proliferation, and CYP activity) to probe cancer progression.➢Designed, constructed, and validated 4+ systems to increase the physiological relevance and utility of scaffold-based 3D tumor models, including automated PK/PD studies and a fluidics-based system that better recapitulates in vivo nutrient delivery and tumor structure, including the incorporation of blood-vessel-like structures. ➢Drove the development of scaffold-based 3D cell culture systems to expand the capabilities, including models that offer the ability to spatially define specific cell types in tumor-like structures to better recapitulate in vivo tumors.➢Worked with commercially available analysis software (e.g., Prism, FlowJo, and ImageJ) and custom-made statistical tests to analyze data and ensure statistical accuracy.➢Trained and oversaw six undergraduate students or junior graduate students, each working on separate projects.➢ Responsible for ordering and maintaining essential reagents and supplies, coordinating calibration and repair of equipment, and maintaining the group cells bank.

Optimized a variety of synthetic organic reactions under anaerobic and aerobic conditions, focusing on a sonogashira coupling reaction, increasing the yield of the product by more than 40%.

➢ Leveraged Python to develop a gas chromatography retention time prediction model based on 11,000+ training points via 28 training compounds and a variety of instrument settings and column properties.➢ Responsible for troubleshooting, repairing, and maintaining 3+ GC instruments.

Assisted in validating fiber optics as a method to quantify the API concentration during dissolution studies, under GMP/GLP guidelines, via comparison to a standard HPLC analysis, reducing the in-person time by 5+ hours.