Longmont, Colorado, United States
Highly motivated, creative project manager and leader of scientific projects with a proven track record of empowering team members toward successful client collaborations. Combining Certified Associate in Project Management and Master’s degree with background in industry, medical devices, diagnostics, microbiology and immunology to reach project goals and milestones in a multi-entity collaborative environment. Resilient and readily adaptable to shifting priorities. Possesses excellent leadership, organizational, and problem-solving skills.
• Elevated to project manager for major fortune 200 pharmaceutical company during medical leave of director. Led technician and design team to complete accelerated milestones on time resulting in realization of critical $120,000 revenue for 2020 fiscal year. • Guides multiple projects from initiation through closure. Known for chairing efficient meetings and excellent stakeholder communication across differing locations and technology platforms. • Executes product development throughout product life cycle across multiple platforms including design control, feasibility, optimization, validation, statistical analysis and pre-clinical development within GxP systems as project manager and technician. • Considered key member of Product Development department with reputation as reliable, dependable and high-performing point person for cross-department needs and problem solving. • Subject matter expert for ISO and FDA required Design Control and Risk Management systems within department, developing project-specific Design Control deliverables for management group and audit review. Called upon to represent department during ISO/MDSAP audit. Trainer of colleagues and department director on Design Control systems. • Owner of department clinical specimen system including vendor relationships, HIPPA and patient privacy regulations.
• Multifaceted diagnostic test developer spanning ELISA, chemiluminescence, laterial flow rapid test. • Diagnostic ELISA and lateral flow immunassay development for filoviruses, Ebola virus and Marburg virus and Lassa virus. • Product optimization and feasibility for atherosclerosis biomarker and companion diagnostics. • Contract development of serum assay for high-throughput laboratory. • Antibody conjugation, ELISA optimization, sensitivity/specificity, LOD/LOQ determination. • Small scale chromatography. Research reports and presentation. • Pilot lot production including GMP/GLP practices, sensitivity/specificity, LOD/LOQ determination, optimization, assembly, packaging, QC testing, quality system documentation, design control, technolgy transfer, risk management, verification and validation. • Project management, project time lines, project budgets, cross-department communication, CE/FDA filings. Selectra, Envoy, Skylab, DSX automated analyzers, AKTA
Facilitator for adult learners in on campus Health/Wellness and Biology courses. Instruction, assignment grading and student assessment.
• Executed Dengue Virus animal vaccine studies. Vaccine administration, animal wellness checks, necropsy and sample collection. Refined cell-based depletion assay for quality control and antibody analysis of complex serum samples. • Operated under government, biosafety and animal study regulatory environment.