Managed individual contributors in Operations to meet production targets for compliance, supply, strategy, and profit plan. Provided leadership, cross-functional development and technical expertise to Operations personnel and administrative support to personnel in various stages of team development. Responsible for a team of approximately 10-30 people, process equipment, and all activities affecting the team. Worked to maximize the potential of all team members, while fostering collaboration, an environment for progression, continuous improvement of skills, and open feedback. Adapted departmental plans and priorities to address resource and operational challenges. Assisted with the development of team objectives. Executed special projects. Assisted with and participated in regulatory and quality audits and tours. Provided review and approval for investigations.

Led process improvement projects and investigations. Served as the technical reviewer and approver for process changes and investigations. Provided technical support to manufacturing shop floor for in-process analytics and controls. Authored and executed investigations and experimental protocols to support root cause and process changes. Ensured all technical writing met requirements for manufacturing, compliance, and regulatory audits. Participated in regulatory audits as a subject matter expert. Worked with a cross functional team to ensure production requirements are met and equipment reliability is satisfactory.

Monitored and oversaw all upstream and downstream vaccine manufacturing processes (cell culturing, inoculation, and filtration) and reported on process deviations, variations, and potential process improvements. Authored and executed process improvement projects, standard operating procedures, validation documents, technical documents, and study protocols. Determined the breadth and scope of the investigations to identify the appropriate root cause, implemented corrective actions, completed trending analysis, and determined product disposition. Fostered a collaborative relationship with manufacturing floor personnel focused on high quality investigations, right first time, meaningful corrective actions, and reducing the deviation generation rate. Worked with a cross functional team of Vaccine Filling (downstream) SME’s to develop an investigational detailed response to the FDA’s observation. Helped develop and implement playbooks and other key initiatives for production ramp ups. Hypercared downstream and upstream manufacturing processing for ramp up of production and process simulations.

Developed work instructions, standard operating procedures, process validations (IQ, OQ, PQ), equipment validations, FMEAs, CAPAs and analytical methods validations. Took part as the quality team member in the development of a new medical device to ensure the device was in accordance with customer and FDA compliance. Used statistical methods, ISO standards, CFRs, FDA regulations, and root cause analysis to improve, diagnose, and develop quality control practices.

Assisted the director of product development in research while also solving physical, chemical, and biological issues by designing and implementing experimental protocols that lead to a more fundamental understanding of material and product properties. Worked closely with manufacturing during scale up of a new product transitioning from R&D to full scale manufacturing. Also gained cell culturing and aseptic processing experience.

Researched and evaluated the physical and chemical properties of biodegradable polymer electrospun nanofiber scaffolds and the likelihood that cardiac cells could migrate and differentiate into cardiac tissue to survive in the human body in hopes of repairing dead cardiac tissue of patients that have suffered from myocardial infarctions or other heart disease. Identified new and unique combinations of polymers that could be electrospun into nanofiber scaffolds that would allow cells to migrate and differentiate into cardiac tissue using rat models. Gained valule cell culturing and laboratory experince.