Lee Blankenship

Skills

Core Program & Project Management Skills
Enterprise commercial product launch and global market readiness
Regulatory compliance & risk mitigation strategies (BLA, EUA, ITAR, DoD security)
Cross-functional leadership (Commercial, Supply Chain, Compliance, Medical, Legal, Regulatory)
Stakeholder engagement & executive reporting
Strategic planning & execution for new product launches
Governance, process optimization, and continuous improvement
AI & digital transformation in program management
Enterprise risk management (ERM) and RAID log management
Post-launch hypercare initiatives and operational stabilization
Agile, Lean Six Sigma, and Waterfall methodologies
Security & compliance leadership (FSO, ITPSO, DoD security clearance)
Industry-Specific Experience
Pharmaceutical & Biotech (Moderna – Spikevax, mRESVIA)
Defense & Government Contracting (U.S. Army ATIS, FBI, DHS, DoD)
Public Safety & Forensics (Rapid DNA implementation for FBI, DHS, DoD)
Telecommunications & Technology (Verizon, Level 3, Genuity)
Corporate & Financial Services (Fiserv, Sabre, Accenture, Thryv)
Regulatory & Compliance Expertise
Pharmaceutical & Biotech: FDA BLA, EUA, sBLA, NABP accreditation, GAVI/COVAX compliance
Defense & Security: DoD ITAR compliance, cybersecurity, NISPOM
Forensics & Law Enforcement: FBI accreditation, ISO forensic standards
Financial & Corporate Compliance: SOX, data security, governance policies
Technology Proficiency
Project Management Tools: Smartsheet, MS Project, Visio, SharePoint, JIRA, Rally
CRM & Business Platforms: Salesforce
AI & Process Automation for workflow optimization and risk assessment
Certifications
PgMP (Program Management Professional)
PMP (Project Management Professional)
Lean Six Sigma Black Belt
Certified Agile Scrum Master
DNA Analyst Training
Mediation & Dispute Resolution

About

Accomplished Program & Project Manager with a proven track record of leading enterprise product launches, commercial readiness initiatives, regulatory compliance programs, and global market expansions across pharmaceutical, biotechnology, public safety, defense, and corporate sectors. Adept at orchestrating high-stakes rollouts, streamlining cross-functional collaboration, and implementing risk mitigation strategies to drive operational efficiency. Leverages AI-driven process automation to enhance decision-making and workflow optimization. Holds PgMP, PMP, MBA, BS, and Lean Six Sigma Black Belt certifications.