Katelynn Montgomery, Phd Email & Phone Number

Pittsburgh, Pa, Us

Pittsburgh, Pennsylvania, United States

Necrotizing Enterocolitis (NEC) is a devastating intestinal disease that primarily affects babies born prematurely or with a medical complication. There are no treatments available to prevent NEC from occurring nor are there any specific clinical signs predicting its development. My research focused on developing a prophylactic treatment for NEC using amniotic fluid exosomes to increase intestinal cell proliferation and improve barrier function, as well as a commercialization strategy.

Silver Spring, Maryland

Responsible for sterile filtration process improvements of the Fluzone commercial manufacturing resulting in a projected $10 million of annual savings. Recruited to be key member of the sites top funded project team to re-submit Quadrivalent High Dose (QIV-HD) Phase II clinical trials. This included data analysis of failed submission and creation of a development path forward overseeing lab scale experiments, pilot plant development, and small scale animal study lots with rapidly changing variables to meet project objectives. Responsible for completing tech transfer of the Fluzone Redesign commodity into commercial manufacturing including process and material improvements.

Preformed daily purification step of cGMP manufacture of Xiaflex. Worked in hands-on capacity to operate chromatography systems, AKTA chromatography controllers, UF/DF skids, performed sterile filtration , and cleaned equipment as required. Revised manufacturing process equipment documentation and assisted in resolving deviations/non-conformances. Preformed troubleshooting for processes and equipment as well as assisted with process, equipment cleaning validations. Ensured work was completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures were followed.

Valencia, Spain

Maintained two cell lines in the cell cultures lab of Valencia Medical School. Learned the techniques of cryopreservation, Western blotting, and slide preparation from paraffin blocks. Practiced staining and karyotyping mouse chromosomes. Conducted semen analyses in andrology lab and assisted in fluorescence in situ hybridization (FISH) preparations. Observed lab practices in vitro fertilization clinic and stem cell research at Principe Felipe Research Center.

Bwiam, The Gambia, Africa

Trained in Philadelphia for a month with Drexel’s Electronic Technical Senior Specialist learning troubleshooting and minor repairs techniques. Also worked with clinical engineering team at Hahnemann Hospital in repairing equipment from all departments. Restored equipment and taught local engineers in The Gambia. Aided nurses in monthly maternal clinics and trek visits to rural clinics. Created master spreadsheet of all equipment at the hospital and tested usability to better manage equipment from abroad. Created database of donated books in the library and trained local librarians to open library to local village.

Worked individually to develop six month study on swelling behavior of polymer solutions using Quartz Crystal Microbalance. Modeled the difference in behavior, presenting updates at weekly lab meetings. Presented final results nationally to other Cordis Corporations. Replicated bulk polymer testing and developed orthogonal tests with other analytical groups.• Manuscript of work was submitted to the International Journal of Pharmaceutics

Contributed to the development of SQM monthly metrics to evaluate suppliers’performance. Presented Supplier Diversity and Corn Derivatives spend analyses to commodity buyers and managers. Supported Supplier Enabled Innovation through the Pediatric dosing device supplier day. Developed lead-­‐time and Minimum Order Quantity metrics in support of the Customer First initiative. Acted as a liaison between chemical suppliers and mangers.

Doctor Of Philosophy - Phd, Bioinnovation

Bachelor Of Science (B.S.), Biomedical/Medical Engineering

Activities and Societies: Delta Phi Epsilon, Drexel Women's Rugby, Weserve, Society of Women's Engineering, Violence Information Education.