Responsible for performing all tasks associated with running the company’s Quality System. Accountable for all Quality System compliance across the entire organization.

• Provided Engineering and Development reports and data to support and implement current processes used to transfer a clinical phase procedure into the manufacturing setting. • Meet deadlines for scale-up processing, clinical trials, registration, validation, and scale-up engineering batches of a polymer-based drug. • Served as the primary resource within the Aseptic manufacturing department to provide instruction and clarification of the product and processes during product transfer. cGMP compliant• Carried out the implementation of a new product formulation through feasibility studies, authorizing necessary redlines through various pilot runs, developing a technical transfer document that was compliant with the commercial customer as well as the FDA, and serving as the liaison with manufacturing during process implementation and registration batches.

• Served as a technical resource for process development, evaluation and qualification projects relating to fermentation, downstream processing, aseptic manufacturing and various manufacturing troubleshooting studies.• Ran various fermentations at the bench scale and pilot scale. These fermentations were performed to qualify proteins, investigate lag times, and various studies involving troubleshooting processes.• Performed work involving downstream processing from fermentations. This work included: testing out spiral-wound modules for diafiltration, final powder physical form studies and final product degradation using heat or acid.• Investigated the source of elevated toxicity and metal counts in through reworking and reprocessing material through precipitation and high pressure filtration.

• Developed bench-scaled processes relating to authoring batch records for the acceptance of raw material qualification and numerous evaluation studies.• Provide manufacturing support for qualification of raw materials at the pilot scale before release.o Authored development reports necessary to accept the raw materials and provided historic insight for future studies through data analysis.• Helped develop and author a new manufacturing process for Master Cell Bank production.o Coordinated qualification procedures necessary for proper product acceptance including functionality testing and deliverable/extractable volume/weight followed up with a report for each.• Carried out and provided support for various new business development activities relating to product degradation and aseptic manufacturing.o Provided development reports relating to the analysis of these results.• Developed an expertise in various downstream fermentation processes including centrifugation, filtration, diafiltration, precipitation and drying methods.• Authored SOPs for the use of standard equipment within the Pilot Lab.

• Served as a liaison with the company and customers while handling complaints relating to microbiological and manufacturing quality.• Coordinated the Out of Specification Corrective Action team across two separate Midwest facilities.• Organized and presented data using Cpk formulas to introduce the processing capabilities of manufacturing product specifications.• Performed work in multiple areas including microbiology, customer support, physical quality and safety.• Managed batch reviews that allowed product to be released within the conformance of the customer and the USDA/FDA.

• Served as a laboratory assistant for an Aquatic Toxicology Laboratory that investigates the costs of contaminants of emerging concern on aquatic life from a molecular level.• Examined bone ossification and cartilage levels via a series of cleaning and staining methods.• Performed various laboratory duties as needed.