Daniel Merkulovich Email & Phone Number

Windsor, Colorado, United States

● Applied working knowledge of FDA and EU guidelines to author and support execution of Process Performance Qualification (PPQ) protocols for an additional cGMP filling site.● Collaborated with Production staff to identify improvements, address failure areas, and increase overall process confidence. Provided on-call support for Manufacturing teams during bulking and filling operations.● Identified alternate manufacturing components to increase robustness of bulking process. Reduced business costs and delays by creating a SolidWorks model and utilizing in-house fabrication capabilities.● Conducted engineering studies to mimic an aseptic manufacturing environment, ensuring ALCOA+, GxP, and gowning practices were followed during processing steps and immediate equipment troubleshooting.

Fort Collins, Colorado, United States

Performed qualification and validation activities on process aid equipment for drug manufacturing.

Windsor, Colorado, United States

Responsible for development and technical transfer of manufacturing process to support drug production.

Windsor, Colorado, United States

Windsor, Colorado, United States

Bulking operator in Development Manufacturing Department. Responsible for GMP compliance, while troubleshooting and executing non-commercial process. Identified and implemented controls to maintain operator safety and product quality.

Fort Collins, Colorado Area

For this project, three peers and I were tasked with creating a new device for protecting a drug- coated balloon for use in Angioplasty and evaluate its performance with the currently marketed device. One of my individual tasks was to research, design, and assemble a unique testing model with anatomically accurate blood flow for physical device testing and validation. As a team, we developed specific test protocol for experiments, performed statistical analysis of results, and reported findings in written technical report to representatives from UC Health and Medtronic.

Fort Collins, Colorado Area

I have performed tasks with different technologies in a research lab. Focusing on platelet adhesion and activation, we investigated various titanium surfaces that minimize immune response. The purpose is to develop a surface or coating that could be used on biomedical implants to increase the efficiency. Primary duties included individually performing supporting experiments while following safety and laboratory guidelines.

Medical Center Of The Rockies

This immersion program provided me the opportunity to shadow clinical professionals and observe the biomedical devices and technology in use. I would individually meet with doctors and nurses to discuss the technical side of devices currently in hospitals, often focusing on the ease of use and reliability concerns. From these issues, I would identify and discuss potential improvements of observed devices to peers within the program. This experience allowed me to lead a senior design team which centered around improving the performance of a current angioplasty catheter.

Fort Collins, Colorado Area

Designed and successfully built machine to make a PB&J sandwich. With three other students, my team created an automated robot that met specific component criteria and stayed below budget. I was tasked with researching and analyzing all required parts for reliability and communication with other circuit elements. I coded micro-controllers and combined them with sensors and actuators to work as a single unit. This project required in-depth circuit analysis. Both theoretical and physical investigations were utilized to fine tune the system and prevent current overloads or damage.

Denver, Co

For this company, I started as an entry-level lifeguard and developed the skills necessary to become the Assistant Manager. From this position, I managed two neighborhood pools, along with maintaining safe and clean environments. This included keeping detailed chemical and supply inventories for both water and on-deck safety. Additionally, I was responsible for maintaining accurate service records for the pumps and filter components for each pool. This involved performing preventative routine upkeep for daily operation and emergency maintenance.

Bachelor Of Science - Bs, Biomedical/Medical Engineering

Bachelor Of Science - Bs, Mechanical Engineering