Rilwan O. Afinni, ASCP, CSM, MBA, PMP

Blaine, MN 55449.

E-mail: adxgmk@r.postjobfree.com Tel: (612)889- 6632

PROJECT MANAGER

SUMMARY

Accomplished Healthcare laboratory Project and Program Manager with 10+ years of initiating, executing and completing projects. Expertise in driving development process from ideation to implementation while overseeing and managing project scope, budget and production cost. Seeking greater responsibility in Project Management, where I use my creativity, data, and technology to drive innovation.

PROFESSIONAL EXPERIENCE

Program Manager

August 2022 – April 2023

Renown Health, Reno, NV.

Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives, while ensuring compliance, with domestic and international regulations.

Implement and maintain processes and systems to ensure accurate, complete and timely submissions to regulatory agencies to meet business objectives.

Participate in new product development and in preparing new products for implementation.

Anticipate and assist in the resolution of regulatory and quality issues and potential non-compliances and recommended corrective actions.

Maintain workflow by performing quality assurance checks on all revenue functions pertaining to each billing site.

Manages all laboratory quality data and maintain regulatory records of all company activities.

Ensure and maintain all laboratory Quality Management System and LIMS.

Maintain Licensure, Accreditation and Regulation of all Clinical and Anatomical laboratory platforms.

Project Manager January 2022 – July 2022

CDC Foundation, Atlanta, GA (Minnesota Department of Health (MDH))

Guided the MDH infectious disease laboratory's overall coordination, status reporting and projects stability.

Established and implemented project management processes and methodologies for the IT community to ensure projects are delivered on time, within budget, adhered to high quality standards and meet customer expectations.

Assembled 5 project plans and teamwork assignments simultaneously.

Directed and monitored work efforts, identified resource needs, performed quality review; and escalated functional, quality, timeline issues accordingly.

Tracked key project milestones and adjusted project plans and resources to meet customer needs.

Communicated with Stakeholders about impacted project scope, budget, risk and resources.

Assisted program managers in partnering with senior management of the business community.

Monitored and coordinated clinical data analysis of the Sequencing and Bioinformatics unit.

Managed 8 cross functional projects of medium to high complexity.

Reduced test results turn-around-time by 12% within 5 months of management.

Project Manager April 2015 – January 2022

Allina Health, Minneapolis, MN

Managed a multi-million dollar StemCell Technologies “RoboSep” Cell separation project, which cut down processing timeline by 60%.

Led development of program and project charter, work statement and business vision statement.

Built successful project plans covering objectives, resources and staffing to meet schedules.

Obtained needed resources by strategically negotiating with stakeholders and outside suppliers.

Established and applied quality objectives, criteria standards and levels using appropriate quality management methods with integrated tools and with stakeholder input (KPIs, scope definition).

Established a project risk register and executed detailed plans to ensure risks mitigation.

Monitored and controlled the financial status of the project.

Scheduled meetings to reflect on project milestones.

Communicated with Executives and Stakeholders throughout project life cycle.

Consulted with business leads to develop and implement achievable franchise plans.

Managed a $2.5M Agilent Technologies-Allina Health Dako-Omnis Project to automate FISH and Histocompatibility laboratories processing.

Regulated and maintained relationships with internal and external R&D teams.

Coordinated project deliverables for assigned projects between cross functional teams.

Orchestrated group IVD studies and validated several testing platforms.

Provided IND and NDA summary reports.

Managed Phases I, II, III and IV of clinical trials with the Clinical Trial Management System.

Identified and managed the development of oncological therapy protocols.

Tracked and forecasted budget, metrics, timeline progress for all project deliverables.

Ensured routine project closure within appropriated timeline.

Saved approximately 8% in operating costs within 6 months team coordination.

Medical Laboratory Scientist October 2006 – April 2015

Allina Health Cytogenetics, Minneapolis, MN

Processed and analyzed prenatal, hematology, oncology and molecular cases.

Led daily on-site direction and promoted the use of clinical best practices.

Ensured effective and timely clinical research performances and presentations.

Updated and programmed automated laboratory devices.

Maintained laboratory inventory and supply Kanban system.

Organized, updated and implemented clinical lab trial protocol per FDA and EPA standards.

Partnered with other Allina facilities, departments, or physicians to resolve systemic issues.

Facilitated quality control of equipment, and reagent validation.

Managed the Research & Development unit of the laboratory.

Performed in-vitro preclinical oncology trials.

Oversaw laboratory biorepositories including cold storage and the bio bank systems.

Ensured all CLIA, CAP, OSHA, and other compliance programs, standards and regulations were followed.

Project Manager

January 2003 – September 2006

Kymanox, Morrisville, NC.

Managed the drug product formulation and the product design protocols for the technical team.

Led the early process development efforts.

Responsible for influencing and effectively facilitating cross functional decision making in a matrix environment.

Managed Quality control principles and applications to new pharmaceutical product development.

Orchestrated day-to-day team communication, periodically report project progress to key stakeholders and/or CROs and escalate concerns when necessary.

Ensured that best practices, knowledge exchange and continuous mentoring and training of team members.

Managed multiple cross functional GCP and GMP submission and inspection readiness.

Ensured projects were delivered on time, within budget, and delivered with quality results that meet client expectations.

Developed project structure, detailed schedules, estimates, resource plans, and status reports.

SKILLS

Project/Program Management, Business Plan, Data Analytics, Waterfall, Agile SCRUM, Lean Six Sigma, Beaker, EPIC, Excellian, JIRA, Product Development, Quality Management, CLSI, MediaLab, Microsoft Office (Excel, Projects, PowerPoint), Technical Writing, Negotiation, Visio, Orchard, SharePoint, Tableau, Python.

EDUCATION

Master of Business Administration January 2019 – May 2021

Augsburg University, Minneapolis, MN

Con-Ed. Courses, Biomedical Sciences August 2014 – December 2016

North Hennepin Community College, Brooklyn Park, MN

Bachelor of Science, Biological Sciences January 1998 – December 2002

North Carolina State University, Raleigh, NC

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