Continuing my evolution in the organization, I transitioned into the dedicated manager of the quality management system (QMS). I had been designing both structure and content while implementing most policies for the QMS since early in the manufacturing commercialization process. However, the increased scrutiny to the implementation of cGMP requirements in the manufacturing process required an independent Quality Assurance (QA) manager to ensure product integrity, industry standards and best practices are met, regulatory compliance, and minimize business and personnel risks. In this dedication position I meticulously overhauled all QMS documents for rigorous management review, greater process control, improved traceability, and minimized non-conformance. Furthermore, I took on the role of coordinating corrective investigations and root cause analyses to address identified manufacturing non-conformances.This role requires hosting regular onsite customer quality audits to demonstrate conformance to the established QMS. Audits were nearly universally seen as successfully with observations focusing on mutually beneficial improvements. I also monitor FDA guidance to ensure the manufacturing process is consistent with developing regulations for cell therapy ancillary reagents. I proactively contribute to the conversation on identifying critical process parameters and setting relevant acceptance criteria by regularly attending clinical conferences and publishing marketing material. The success of the organization is rooted in the ability to first understand the needs of cell therapy manufactures, and then deliver solutions that deliver their strict success criteria.

ManufacturingIn this role I assumed responsibility for all manufacturing activities related to the production of the cell isolation reagent product line. The established process included three primary areas; microorganism fermentation, enzyme chromatography purification and fill-finish operations with quality control testing. Responsibilities for this also including raw material supply chain management, product inventory management and establishing operating budgets. Furthermore, I regularly worked directly with users of the products I manufactured to provide technical support, troubleshooting and cell isolation optimization strategies.Business Development & Account ManagementWorking in a small organization also required me to continue some of the business development activities initiated earlier in my tenure with the company. In that capacity I fostered collaborations to develop additional innovative formulations the market was requesting, maintained clinical key accounts and contributed to content marketing.

Manufacturing Operations• Direct scientists responsible for manufacturing a portfolio of blended purified enzyme reagents • Coordinate process optimization, product development and assay development projects • Manage raw material supply chain, product inventory and customer service activitiesBusiness Development and Marketing• Implement business development strategies for cell isolation enzyme markets• Manage the key clinical customer accounts • Involved in technical sales of research and clinical reagents• Represent company at technical and clinical conferences to build and manage relationships with key accounts and establish collaborations Quality Assurance• Established and maintained Quality System• Authored/reviewed/edited manufacturing batch records, SOPS, release testing, deviation/OOS reports, change control documents and training records• Assure implemented protocols and processes used met regulatory requirements and industry best practices• Prepared for, facilitated and followed-up on external customer site audits to ensure compliance with Quality System

Product Development• Collaborated with cell biologists to design and launch novel application specific tissue dissociating enzyme products for research and clinical cell isolations• Established reproducible processes for blending proteases, by enzymatic activity, for specific applications including islets from six species, human hepatocytes and human adipose derived stromal cells• Introduced formulation improvements that increased the shelf life stability of blended enzymes relative to similar competitor products.Process Development• Developed novel protease activity assays for product development and implemented routine use in quality control of manufactured enzyme reagents• Managed process optimization and scaling up projects for the improved yield and efficiency of collagenase and metalloproteases used in preparation of tissue dissociating enzyme products

Purdue School of Engineering and TechnologyDepartment of Technology Leadership and CommunicationMotivated by a desire to contribute to the development of STEM professionals in training I joined the team of technical writing and organizational leadership faculty in the School of Technology and Engineering in part-time role. I have since served as an instructor for an upper-level undergraduate writing course titled ‘Written Communication in Science & Industry’. My goal in this capacity is to provide students with the skills required to be effective communicators in their professional endeavors. In addition, having developed insight into the challenges of recruiting and retaining talent for a biotechnology company, I hope to provide students strategies for presenting both technical and soft skills for future opportunities. This role is mutually beneficial as students help me stay current with technology development and industry trends. Furthermore, I continue to improve my own writing and editing skills, and am regularly challenge me to communicate more effectively. I routinely apply these skills in my other professional roles.

• Directed assay development scientists in experiment design and execution for novel high through-put immunoassay platform development• Served as protein biochemistry subject matter expert for engineering teams designing detection technology

• Managed laboratory for development of novel immunoassay for autoantibody quantitation in sera samples• Analyzed data and interpreted results for critical business decisions• Wrote grants for small business technology development

• Optimized expression and purification of recombinant proteins using bacterial and cell-free expression systems• Composed and implemented a business process for protein expression screening service• Designed projects and experimentation for custom contract development service• Trained field sales team on features and benefits of recombinant protein product line• Presented technical seminars to support sales team to key pharmaceutical and academic research accounts

Investigated the metabolic regulation and cytoskeletal structure of mature human erythrocytes using recombinant protein expression and purification to develop protein-protein interaction assays.

Designed and executed contract testing projects on commercial personal care products, pharmaceuticals, polymers, and material coatings for failure analysis, reverse formulation analyses and patent infringement litigation.Generated quality system documents for a cGMP/GLP laboratory and supported quality compliance activities.