Domenic J. Barnabei, Mba Email & Phone Number

Greater Pittsburgh Area

• Project Management and consulting on a regulatory-mandated roll-out of services for members in Medicare and Medicaid. Managed vendor contacts and relationships and provided background for contract development.• Process consulting for new workflows across departments and vendors. Used client feedback, regulatory requirements and user stories to identify process needs.• Develop detailed process flows of existing processes as well as proposed processes using Visio. • Interviewed stakeholders and subject matter experts to understand workflows, issues, and perspectives on the data management landscape of a new program in a highly regulated environment.• Developed a framework for understanding and prioritizing data management issues in a recently launched program. Presented findings to senior management and fielded feedback and challenges.• Drive working meetings to facilitate agreement and decision making among department leadership.• Develop resources, documents and protocols for teams across organizations.• Facilitate change and innovation development with medical and health plan leadership.

Pittsburgh

I have consulted with launch, pre-launch, and other early stage ventures to spot roadblocks, build partnerships, and create efficient startups.•Development of Business Plan and creation of LLC. Extensive research into market and revenue models and sources of public and private funding. •Develop business plans for startup clients in Non-Profit, 3D printing, engineering, and biotechnology/pharmacogenetics•Research and resolve client concerns regarding financing, launch, and regulation•Evaluation of facilities for laboratory operations and capacity•Developed business plan for non-profit startup and supported interface with funding agencies•Consulted and advised on vendor relationships, creation of quality management systems, regulatory compliance, and document control for early stage genomics venture.

Greater Pittsburgh Area

During my education at Katz, I concentrated in Strategy and Operations. I further developed my skills and gained valuable knowledge through my coursework and experiential learning. Some of my notable experiences and accomplishments are:•Major contributions to the new product commercialization efforts of a small, Pittsburgh-based medical device manufacturer•Over twenty interviews of medical professionals, researchers, software developers, startup founders, innovators, patients, and caregivers for Commercialization project•Exploration of emerging trends in interventional patient relationship management software development and application•Analysis of new 3D printing technologies in drug manufacture for Competitive Intelligence coursework•Recipient of the Brosius Creativity Award for the design and prototyping of an augmented balance sensing prosthesis for patients with balance disorders•Entrance of my prosthesis project into the Pitt Innovation Challenge•Interviewing, research, and analysis for projects regarding the innovation pipeline of a Pittsburgh-based biotechnology firm•Multiple classroom-based pitches to VC’s and redesign of pitch based on VC feedback.

Greater Pittsburgh Area

I consulted with the firm to aid in change management and process transition and stayed on to find new markets and establish new partnerships.•Implemented process optimizations through workflow and software improvements, including the redesign of CRM software •Researched and analyzed industry trends to create new products and enter new markets•Established strategic partnerships with local law firms and software vendors•Drafted business plans for two new business ventures •Gathered intelligence from government and professional stakeholders to identify ongoing changes in policies and competition

Greater Pittsburgh Area

I managed the daily operations of a CLIA certified clinical laboratory and supervised 21 laboratory professionals across multiple testing platforms for the characterization and chemotherapeutic response patterns of various origins and subtypes of cancer. I also managed the launch of their histology and biomarker platform and was part of the effort to commercialize mulitgene predictor platforms in stage II colon cancer and stage II NSCLC.• Process development and optimization of lab developed tests• Managed the Immunohistochemistry and Genomics laboratories from development to implementation• Cross Departmental project management actively working with Laboratory, Quality Assurance, Client Services, Medical Records, Marketing, and Sales • Managed QA/QC system and procedures• Troubleshooting and interaction with Surgical Oncologists and other clients• Gathered requirements and integrated the StarLIMS information management system into lab processes and allocated resources for the testing of user end applications in this platform.• Employee supervision, development, training, and safety• Interviewing of internal and external job applicants • Redesign of laboratory function, layout, and workflow using Lean principles to transition from a cell culture to genomics and histology facility

Greater Pittsburgh Area

I worked with laboratory management to create and fill the Lead Clinical Technician II position in the Clinical Laboratory at Precision Therapeutics in response to institutional needs in quality management, team leadership, technical expertise, training, change management, crisis management, and interdepartmental relations. •Managed day-to-day laboratory operations, troubleshooting, and quality management in a CLIA and NYSDOH compliant laboratory•Coordinated with software development and IT to meet clinical laboratory needs•Planning and workflow management during laboratory expansion•Trained technicians on cell culture reading and immunocytochemistry•Interviewed technical and supervisory staff candidates•Trained sales team on laboratory processes and timelines•Designed expansions and new laboratory facilities using Lean and DFSS concepts•Executed launch, training, and workflow design for addition of second shift operations•Performed audits of vendor facilities, processes, and documentation•Evaluated client trends using heatmaps and deep analysis of case characteristics

Greater Pittsburgh Area

As a Clinical Laboratory Technician at Precision Therapeutics, I performed the intake, processing, and maintenance of live-tissue cell cultures from patient tumors for diagnostic testing in a chemosensitivity assay. I prepared cell growth reagents as well as standard chemotherapeutic agent applications in accordance with standard operating procedures.•Monitored cancer cell cultures using microscopic analysis for cell health, cell morphology, and bacterial or fungal contamination. •Daily quality auditing of laboratory equipment and processes •Documentation of patient demographics and specimen characteristics.•Created and maintained laboratory standard operating procedures and processes •Performed a time-sensitive procedure involving robotic liquid handling and dosing of patient tumor cells in cell assay plates•Worked extensively in immunocytochemistry techniques, applications, and analysis •Collaborated with the medical director on the immunocytochemistry quality assurance process•Assisted with the migration of lab techniques from a manual to robotic process•Designed, implemented, and documented validations of new processes and equipment

Greater Pittsburgh Area

I was head coach of 7th and 8th grade boy's lacrosse team from 2001 to 2003, and proceeded to a position as assistant Varsity and Junior Varsity coach until 2007. I was responsible for conditioning, practice organization, game scheduling, game personnel, travel discipline, and the general management and well-being of a group of 60+ adolescents.As a coach I was focused on fundamental skills, organization, training, and sportsmanship. I created practice and training plans and worked to set an example of excellent leadership and work ethic.

Murrysville

As a contractor through Adecco and Spherion, I was trained by Respironics full-time staff and worked with them in their quality management system. I conducted the training and integration of additional contractors. In addition to system updates based on quality needs, I conducted ongoing conversations with technical staff to document and identify device component issues and coding in the quality database.•Led and trained several full- and part-time employees in the operation and protocols of an SAP QA/QC database•Maintenance of quality procedures of complaint evaluation in an FDA regulated environment•Employed physical product examples for training purposes and technical examples•Worked closely with Respironics staff to assist them in readiness for FDA audits

Mba, Strategy And Operations

B.S., Cell And Molecular Biology

Activities and Societies: Recipient of the Maximilian G. Duman Biology Scholarship and Saint Vincent Leadership Grant. Letterman.