As the PMO Manager and Sr PM, I lead the Corporate Program Management team, steering high-impact projects that align with our company’s vision. I excel in crafting effective program strategies from start to finish, ensuring optimal use of resources, and successful project outcomes. My portfolio includes managing high-profile corporate projects, business systems implementations, and overseeing IVD and non-product software development in compliance with ISO and FDA regulations. I'm skilled in meticulous planning and risk management, proactively tackling challenges, and fostering a collaborative work environment. My projects primarily support the Quality, Finance, IT, and Operations teams, covering ERP implementation, Quality Compliance Gap Analysis, Facility Validation, and New Product Development. I take pride in my ability to manage multiple projects remotely, thanks to strong personal time management skills.

As the lead founding partner, I provided visionary leadership and executed the establishment of our LLC. As the General Manager, I ensured full compliance with CLIA regulations, achieving certification and maintaining high-quality standards. I built a talented interdisciplinary team, fostering a culture of excellence and collaboration. I also formed a partnership with Yale, integrating our processes into their Saliva Direct program. Additionally, I managed budgeting, financial planning, and resource allocation to ensure our laboratory’s financial health. My consulting projects included COVID-19 campus surveillance testing programs, cleanroom design, and GMP consulting.

As the Sr Director of Operations and Program Management, I ensured FDA compliance through comprehensive regulatory analysis and worked with R&D and bioengineering teams to develop novel products and aseptic procedures. I standardized project management tools, established best practices, and mentored project managers. I built key partnerships and designed a future satellite facility in the Southeast, negotiating contracts that reduced material costs and brought the project in 40% under budget. I developed strategies for scaling manufacturing operations and authored essential QMS documentation. I also created and executed validation protocols, launched our first product, and managed growth with a $5MM CAPEX and $2MM OPEX, all while championing cGMPs and GDPs.

As the lead project Manager, I designed, planned, and executed the relocation of the Manufacturing department to a new 100,000+ square foot facility. I led the relocation of over 600 employees and 250 pieces of specialized equipment, ensuring seamless installation of automated systems and scheduling qualifications and validations ahead of launch. I carefully planned the relocation tasks to maintain the production schedule, ensuring that finished goods inventory and WIP were unaffected. I collaborated with engineering, operations, quality, materials management, and other departments to ensure the project's success and timely completion.

As the experienced Laboratory Technologist, I was responsible for training new employees, performing statistical process controls (SPCs), qualifying testing equipment, reviewing and approving diagnostic reports, and implementing Lean practices in to the lab. I also performed quantitative protein analysis via nephelometry, aiding in the diagnosis of auto-immune diseases, celiac disease, several forms of cancer, and many other diseases or illnesses.

Project successes included increasing laboratory capacity by 25%, developing workflow improvements that decreased lab turn around times by 10%, and improving reporting accuracy.

At Rigid Alaska, a custom manufacturer of roofing, siding, and decorative metal panels, I oversaw all manufacturing operations. I coordinated production for large-scale government projects while managing daily workflows, monitoring product quality, production KPIs, and meeting deadlines. As a startup, I established standard operating procedures, inventory practices, safety initiatives, and performed equipment qualifications and preventative maintenance