Shelley Fitzgerald Email and Phone Number

• Two years of project management experience within the medical device industry. Managed multiple diagnostic development projects including both internal and external collaborative projects with partner companies. Responsibilities included development of project scope, resource and time allocation, and budget management. • Managed project groups comprised of 3 – 5 team members. Exceptional leadership skills and ability to influence stakeholders enabled the timely completion of project deliverables, identification and resolution of challenging technical problems and allowed my projects to remain organized and on schedule.• Standardized and optimized the company’s peptide-microparticle conjugation process to improve traceability, lot-to-lot variations, and reduce time and cost-of-goods. Responsibilities included designing and executing experiments to evaluate process variables, drafting standard conjugation protocols, drafting worksheets for recording process deviations, and training and implementing new processes. • Performed and directed hands-on laboratory experimentation including enzyme-based ligand-binding assays, conjugation of dyes to peptides, conjugation of peptides to solid microparticle supports, and production of lateral flow strips. Responsibilities included maintaining a detailed laboratory notebook, drafting protocols, designing and conducting experiments, quantitative data analysis, writing technical reports, and presenting experimental results. • Interfaced directly with critical raw material suppliers to resolve quality issues, prepare for process scale-up, negotiate bulk pricing, and identify secondary suppliers.

• Developed biodegradable, sterile, two-component hydrogel formulations that could be mixed and applied using aerosol spraying mechanisms for post-operative adhesion prevention.• Synthesized polyethylene glycol and Pluronic based hydrogel formulations with varied solid concentrations and initiator and catalyst concentrations. Evaluated ultraviolet and redox crosslinking methods. The swelling, degradation time, modulus, viscosity, burst pressure, and Tg of the hydrogels were characterized.• Designed an experimental test method to measure the amount of force required to extrude hydrogel formulations through syringe needles using an Instron mechanical testing system. The measured forces were calibrated against a set of qualitative rankings to determine the maximum amount of force that a person could apply to a syringe to easily extrude the materials. The maximum force was used as a threshold to determine which formulations were extrudable.• Assisted with small animal clinical studies to evaluate the efficacy of the hydrogel formulations.