Responsibilities are to provide oversight of the Site Technical Services Vaccines and Gene Therapy Drug Substance/Drug Product Groups while managing departmental milestones and establishing long term group direction.

Responsibilities are to provide oversight of the day-to-day operation of the Site Technical Services Group while managing departmental milestones and establishing long term group direction.

Responsibilities were monitoring, troubleshooting, and optimizing a bacterial fermentation and protein purification process. Unit operations include Centrifugation, Depth Filtration, NFF, TFF, Ion Exchange Chromatography, CIP and SIP. To assist with the monitoring of such a highly automated and technically challenging process, I developed algorithms to automatically extract continuous process data from the process historian, perform engineering calculations on the data, and then store this new analysis data in an integrated database. These continuous datasets often exceed 1 millions rows of some twenty to fifty columns of data. This analysis data as well as the raw continuous are then used to model (multivariate - projection to latent structures and eventually theoretical models such as mass balance equations) critical attributes such as yield and product purity. This type of data analytics is regularly used to support troubleshooting and continuous improvement activities. I am Six Sigma Green Belt certified with multiple years of experience at leading cross functional teams to resolve highly technical issues.I am also responsible for authoring, executing, and maintaining all related process validation activities as well as providing SME input and root cause analysis support for process related quality investigations. I led a CIP optimization project, which eliminated the wasting of nearly 455,000 gal/yr of WFI. To guide this optimization exercise, I deployed an iterative process of review/modify/monitor to help us fine tune the cycles to capture optimal results. I led an evaluation of the variability of a raw material, which has since resulted in a sustained yield increase of 13%. I have also taken responsibility for maintaining and developing the facility’s Multivariate Process Monitoring program (SIMCA).

I was the lead clinical scientist for the upstream process (Media Preparation, Seed Expansion, Fermentation, Flocculation, Centrifugation, and Normal Flow Filtration) of a phase I clinical product. The initial responsibilities were primarily focused on facility fit and automation code design/development. Those activities were followed by the authoring of SOPs for new equipment as well as the authoring of the new batch records and compounding records. Once these new documents were drafted, I spent several weeks performing both classroom and on the floor training for manufacturing technicians and process engineers. The following phase of the project included both code shakedown and water batch execution to ensure the process was designed to satisfy all technology transfer requirements. Once the process was confirmed to be ready and the manufacturing support was trained and confident, I lead the day-to-day floor activities associated with the clinical batch execution. The clinical campaign was 100% successful from start to finish with batch yields that met or exceeded development's expectations and batch quality that was perfectly in-line with lab scale experience.

Statistical Process Control (SPC)/Process InformaticsDeveloping and maintaining our process monitoring technologies were the primary responsibilities. My main accomplishment in this position was to develop an automated discrete process data and product stability monitoring tool. I lead the technology development, implementation, and validation activities to a level that surpassed the expectations of global business technology (BT) management. I also attended a multivariate (PCA/PLS) course from UMetrics and learned to develop batch trajectory models. This approach to modeling was highly successful in predicting processing abnormalities in unit operations from fermentation to column chromatography. I also developed an understanding of various statistical analyses such as Multivariate Linear Regression, non-Parametric Analyses, and Process Capability. Other activities included New Drug Product Specification derivations and agency submission documents. I also supported numerous investigations and commitments. All together this position was a great opportunity to develop a highly coveted skill set, especially considering the new FDA guidelines, and to gain experience in a GMP environment.