Abzena in the Bristol area specializes in Antibody Drug Conjugations (ADC), bioconjugate, and linker payload services. As part of the manufacturing team, I am on the floor helping create these for our clients. With my manufacturing experience, I'm able to offer input and carry out tasks to improve the manufacturing process. Updating Standard Operating Procedures (SOPs), batch records, validation documents, etc., to continue making quality product and keep manufacturing up to date with regulations. I've brought my experience with GDP to Abzena to help keep our documentation compliant with FDA's ALCOA+ guidelines. I'm a firm believer in the saying "Perform what is documented, and document what is performed." GDP ensures we have the evidence to back up our claims that our product is top of the line in the industry.

Oversee that manufacturing of products are performed under ISO and cGMP guidelines. Initiate and conduct any nonconformance and out of specification investigations related to manufacturing. Develop, review, and update manufacturing and testing documents (i.e.: Batch Production Records, Work Instructions, and Incoming Inspections) with the goal of streamlining the manufacturing process to ensure quality. Process customer orders under Globalized Harmonized System. Work with other departments in troubleshooting problems and implementing changes to the manufacturing process.

Conduct testing related to stability, customer complaints, and validation of product assays. Maintained and reconciled inventories of product kits, raw materials, and manufacturing equipment. Monitored and maintained manufacturing equipment by scheduling and working with third party vendors for calibrations and preventive maintenance. Participated in cross department meetings for troubleshooting issues, product transfer, process development, and scale up.

Working for the Biology Department, the main function of the Biology Lab Technician was to help prepare materials and tools for classroom lab experiments. Prepared agar plates, made acid and base solutions, prepped animal specimens all according to lab manuals. Set up and gave professors their materials for lab experiments based on their class sizes. Informed supervisor supply status at the end of the semester while cleaning, inventorying, and prepping classrooms for the next semester.

Internship focused on improving Taq polymerase expression in E. coli cells. Reading research papers and discussing ideas with the professor, experiments were created and carried out. From there investigation of results and feedback on how to proceed new experiments were created and carried out culminating in a research paper on my findings.