Tomas Krupicka

About Tomas Krupicka

Accomplished and dynamic executive leader with extensive experience in the pharmaceutical and biotechnology sectors, delivering measurable results on a global scale. Recognized for combining senior executive leadership with a hands-on approach, working seamlessly with teams on the shop floor to promote collaboration, innovation, and operational readiness and excellence. Highly flexible, approachable, and committed to achieving transformative outcomes by engaging stakeholders at every level.Key Strengths• Global Project & Team Leadership – Led multi-site, cross-border initiatives from concept to delivery, achieving strategic objectives under tight timelines and budgets.• Operational Excellence – Delivered best-in-class processes, cost optimizations, and compliance programs across multiple global sites. Known for implementing Lean/Six Sigma initiatives, reducing operational costs, and improving efficiency while maintaining top-tier regulatory readiness.• GMP Manufacturing Expertise – Supported drug substance and drug product manufacturing programs in alignment with U.S. and international regulatory requirements, providing hands-on technical, operational, and project execution leadership.• Transformational Leadership – Played a key role in organizational transformations through post-acquisition integrations, large-scale expansions, and operational scale-ups—driving cultural alignment, capability growth, and long-term competitiveness.• DoD & Government Program Expertise – 7.5 years managing U.S. Department of Defense (DoD) and BARDA programs, delivering mission-critical pharmaceutical and biodefense projects under high-stakes, compliance-driven conditions.• Product Range Leadership – Directed programs across viral vaccines, monoclonal antibodies, recombinant proteins, gene and cell therapies, small molecules, and plasma-derived products.Notable Achievements• Directed operational excellence, safety, process improvement, design transfer, and capital projects across global pharma/biotech sites with on-site, remote, and hybrid models.• Spearheaded post-acquisition integrations and company-scale transformations, enabling rapid capacity expansion and performance optimization.• Built award-winning, high-performing teams, achieving excellence in quality, compliance, risk management, and project delivery.• Consistently created positive, results-driven environments—motivating teams, developing talent, and ensuring timely, informed decision-making that drives measurable business impact.

Experience

1. Founder & Principal Consultant

   Engineex Llc

   Apr 2024 — Present · Gainesville, FL, US

   Consulting Services for the Pharmaceutical and Biotechnology Sector• Providing senior consulting for pharmaceutical and biotechnology projects of all sizes, with expertise in cell and gene therapies, monoclonal antibodies, recombinant biologics, viral vector manufacturing, and vaccine production.• Supporting both domestic and international initiatives for capacity and capability expansion by contributing to facility design, project management, specific product manufacturing or CDMO program development, technical and regulatory assessments, preparation and support for regulatory audits, Quality Management System-related projects, operational readiness, product support (including investigations and scale-up activities), operational excellence, organizational scaling, readiness, transitioning (including acquisitions), and strategies for optimizing systems and processes.• Delivering design reviews for capital projects, supporting initiatives for operational excellence, and enhancing future efficiency in alignment with industry best practices.• Engaging in continuous professional development to stay updated on evolving technologies, regulatory frameworks, and industry advancements ensures readiness to deliver optimal services and complete project execution.

Education

• Private Higher Education Institution, Prague (CZ)

  Bachelor's degree, Management of Organizations

• Secondary Technical School, Kutna Hora (CZ)

  High School Graduate, Automation Systems & Technology / IT

• Private Higher Education Institution, Prague (CZ)

  Master's degree, Strategic Management