Advising product companies and academic labs

• Whole Project Planning and Execution: Initiated all business IT program activities for the implementation of Master Data for Core Lab, Stability, and EM for a large biologics manufacturing site. Ensured successful implementation of modules, management of static data migration, training, change control, and validation, while navigating challenges including delayed start, inspections, and personnel changes.
• MDM SME Consulting: Orchestrated global business process gathering initiative involving 200+ scientific disciplines for #2 pharmaceutical and vaccine manufacturer from discovery through clinical. Identified and negotiated previously unstructured information and registered in ontology/taxonomy system. Further consulted on ALCOA-compliant scientific experiment capture system, streamlined processes, and templates, and reduced IT-maintained templates by 80%. Eliminated the need for 2nd-person reviews, saving money, and enabling a transition to distributed business model.

Led and developed vision and value for applications and processes across LIMS products as member of West Point Quality Leadership. Consulted with global organizations and sites to explore data management, process improvement, and mobility options for labs and shopfloor. Supported global and local response to cybersecurity incidents providing connection to business continuity, recovery, and automation risk analysis.

Shaped shopfloor programs and high-profile quality projects, with oversight of budgets, objectives, business cases, and senior quality team. Developed and implemented strategies for creating, maintaining, and presenting quality systems regulatory review and inspection utilizing GxP, GAMP, LEAN, PAT, Six Sigma methodologies. Developed and institutionalized new and efficient systems to maintain a lean quality minded right first-time business. Developed process and automated management of site regulatory inspections/audits facilitating better interaction with regulators and enabling 3 or more simultaneous inspections.

Drove informaƟon strategy and management in Environmental Monitoring creaƟng division-wide iniƟaƟves. Managed cross-funcƟonal teams responsible for developing, validaƟng, and maintaining quality projects.
Select Accomplishments:
• Saved over 10K producƟon hours, a 1.5 Year NPV from direct dollar savings, while absorbing 20% year over year increases in tesƟng, through a complete real-Ɵme soŌware/hardware system with a decentralized approach leading to increased opƟmizaƟon of availability/Ɵme and combined tasks.
• Developed, validated, and implemented scalable, durable, and pracƟcal Sample Chain of Custody and highly configurable bulk entry system, eliminaƟng the need for 2nd person review and saving 1000's of staff hours.
• Improved custom development and applicaƟon of SLDC waterfall documentaƟon from 3+ months to less than 2-weeks.
Early Career Experience