Staci Martin Email and Phone Number

Various Undisclosed Clients (USA, South Korea, China, Japan, Europe)• Program creation and oversight for multi-product CMO/CDMO including Equipment Commissioning and Qualification, Cleaning/Sterilization/Process Validation, QA, QC, Process Development/Technical Operations (MS&T)• Initiated and implemented Cleaning Development/Validation and Process Validation program strategies for site commercialization • Directed and created programs for new facility build equipment, utilities, and facility commissioning and qualification including cleanroom certification to ISO standards• Remediated multi-site compliance issues for Environmental Controls• Hired, trained, and managed teams to successfully meet project milestones (5-30 direct reports)• Drove stakeholder management strategy and tracking/resolution of risk • Developed and launched project and integrated schedules to meet company timelines; maintained associated resource and capital/expense budgets• Created and executed sitewide training roll-out for commercialization compliance programs• Provided technical and quality review and approval of site documentation including CAPA, investigation and root cause analysis, master plans, and SOPs. Prepared documentation and teams for pre-PAI/PAS; provided audit support