Joseph Koziczkowski
Sr Director, Clinical Laboratory Operations @Pharmaron
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WORK HISTORY
Sr Director, Clinical Laboratory Operations @Pharmaron
Baltimore, MD, US
Responsible for the operations, execution of analysis, business development, overall quality, and the direction and coordination of personnel in clinical laboratory and specimen management.Onboarded new team and implemented training and competency program elevating quality and technical competence, reducing lab errors in study specific events by 52%.Established departmental committee to develop department Core Values and mission statement in turn provided noticeable morale improvement, 100% retention over 15 months, standardized expectations in productivity and behavior, and bonded Lab Team working more efficiently and cohesively.Sourced and implemented new technology for Molecular/ PCR assays, Flow Cytometry and Cellular Identification/ PBMC collections, processing, testing, and storage.Redirected assay management and workflow analysis aligning study assignment, diagnostic testing, and sample management saving department over in 12 months. Protocol development and collaboration with sponsors, customers, business partners, and colleagues.Design and development of study specific Laboratory Manuals along with review and audit of Sponsor provided documentation.Establish and maintain operational budget. Evaluate cost savings initiatives through analysis and review of operational, financial, billing, coding functions, as well as evaluation of instrumentation, supply costs, service agreements, and technology enhancements.Established goals for operational departments, coach, motivate, and evaluate leaders along with observing employee performance, evaluate laboratory productivity by monitoring functional KPIs, TATs, error rate/CAPA, and identifying peak and slack periods, making operational or staffing adjustments.Continuous professional development for department leaders and team members through departmental training, collaborative projects, external education, certification management, and 1:1 coaching sessions.
EDUCATION
Trident University International
Master of Science, Health Science - Public Health
Southern Illinois University, Carbondale
Bachelor of Science - BS, Healthcare Administration
Columbia Southern University
Graduate Certificate, Occupational Safety and Health
Keller Graduate School of Management of DeVry University
Master of Business Administration (MBA), Health Services Administration and Project Management
Naval School of Health Science
Diploma, Advanced Medical Laboratory Technology
Touro University
Bachelor of Science, Health Sciences Laboratory Science
Liberty University
Doctor of Philosophy - PhD, Public Health
SKILLS
ABOUT JOSEPH KOZICZKOWSKI
Diverse background and proven track record in leadership, mentoring, coaching, quality, and process improvement. Strong communication and presentation skills. Practical knowledge and experience of compliance standards with 21 and 28 CFR parts 11, 50, 202, 210, 211, 802, 803, 820, 610, and 510K workup/submission. OSHA 1910, 1915, and 1926; ISO 9001, 9004, 13485, 14001, and 17025; AABB, CAP, COLA, EU and JC. Strategic planning, organizational planning and budgeting analysis for work-flow/workload projections. Contract negotiations, systems integration, and change management. Network and systems management specifically laboratory/ blood bank and document/quality control systems. Knowledge and experience in Lean Manufacturing, Six Sigma, 5S, and Kaizen methods.Result oriented, change agent that has proven results in process improvement, error reductions, quality enhancement, and cost reduction, along with personnel motivation and development.Goals: To work with a team of professionals where I can apply my experience, skills and education to achieve success and improve the quality, administrative processes, efficiency, and team moral.Specialties: Laboratory science/ Operations and Production, Quality, Leadership, Mentorship, Presenter/educator/instructor, Supply and budget forecasting, compliance, QA/QC, analytic thinker, strong quality driven mentality with big picture vision.
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