Cody P. Email and Phone Number

• Managed manufacturing execution software changes for albumin production processes required for yield and time saving improvements. Facilitated and delivered emergency code changes required to continue production due to Covid related supply issues. • Provided automation engineering training and system code update supervision on the MES system during integration of DeltaV and MES team responsibilities.• Led the digitalization of batch and equipment cleaning paper forms and implementation within a new environment.

• Led a $360K Six Sigma Green Belt improvement project that reduced in process sodium variation and adjustments as well as eliminated unnecessary testing by implementing a statistically based factor.• Trained and experienced with multivariate data analysis using Umetrics Simca software to provide insights for yield improvements.

• As a member of the Continued Process Verification team within the PDTS organization, led development of the CPV monitoring program by working with cross-functional teams and writing sustainable product based Plans.• Continuously supported Discoverant software implementation and served as liaison between IT and process experts to develop and update product hierarchies in order to automate process monitoring and analysis.

• Involved in multiple audits (FDA, Kamada, and Internal) and managed all auditor requests in order to retrieve the appropriate documentation and personnel.• Proficient in data management and trending for all manufacturing needs. Supported multiple manufacturing problem solving efforts by compiling and analyzing process data.

• Member of the Process Science and Technical Operations (PSTO) department, working with the Process Knowledge and Control team, monitoring critical quality attributes in manufacturing.• Performed statistical analysis on extended aging times of Fraction I/II/III of the Cohn purification process in order to understand and prevent downstream filtration issues that could result in production batch losses. Compiled results and provided Aging Time Study report to Quality Management. • Collected batch record and quality lab data to create process limits, investigate and determine root cause of data trend.• Conducted trending analysis using LIMs manufacturing data, Minitab software, and other statistical process control software in order to monitor shifts or changes in production and improve process stability.• Improved accessibility of process and protocol information by organizing and updating SharePoint document database and filling knowledge gaps. • Trained in GDP, CAPA and Trackwise 8 for initiating and handling events, as well as cGMP and clean room environment with full gowning procedures for all related manufacturing buildings.

-Managed in vitro testing, system operation, data processing, and traceability of solutions and equipment for clinical trials. Per GLP regulations, this involved accurate documentation and following EHS guidelines and SOP documentation.-Responsible for conjugate staining and chemistry synthesis used in experimental optical glucose sensors.-Optimized polyurethane membrane dipping procedures and trained colleagues on optical sensor and reader device installation, testing, buffer cycling, as well as polyurethane membrane dipping.-Worked with electrochemical team in preparing and validating enzymatic activity of clinical glucose oxidase solutions to be used for in-house as well external trials.-Designed and developed a new glucose oxidase-polymer solution that reduced electrochemical sensor enzyme leaching by 75%.

Dr. Leonard’s Laboratory at Florida Tech- Made solutions necessary for the microbiology teaching and research laboratories. This included gel and plating preparation for bacterial analysis. Also responsible for autoclaving any bacterial infected equipment.

Dr. Wehmschulte’s Laboratory at Florida Tech- Worked on research related to synthesizing a chlorinated boron sphere that alkalizes benzene at room temperature to be used to increase Lewis acidity and reactivity of aluminum and gallium compounds.- Responsible for acid/base cleaning of glassware, replenishing chemical supply, and preparing for relative experiments. Became familiar with work in an inert atmosphere glovebox for air-sensitive compounds and other inorganic substances.