Nnamdi Okeke

Responsible for various aspects of new CDx IHC/ISH product development including evaluation, feasibility, optimization, verification, design transfer, validation, project management, and collaboration with external partners.

• Served as technical lead/SME for development of automated IHC multiplex (3-plex) assay to detect immune cell markers in different solid tumor indications, and Co-technical lead for development of Automated FISH (Fluorescence in Situ Hybridization) Assay to detect gene translocations in Bone Marrow Aspirates.
• Managed multiple projects simultaneously, identified development deliverables on critical path, and proposed solutions to keep project on time, and within budget.
• Presented findings from development activities to pharma partners, conferences, and brought in over $1,000,000 in revenue.
• Established strategic partnerships with external organizations to access unique resources or expertise for collaborative projects.
• Identified areas for improvement in existing products and achieved significant advancements in product development through rigorous testing, and data analysis.
• Drives cross-functional discussions to resolve and countermeasure risks, align on design quality, regulatory, and technical product requirements to ensure scientific validity and proper design of studies.
• Authored different IVDR (In Vitro Diagnostic Regulation) documents and conducted systematic reviews of various scientific literature and SSEDs (Summary of Safety and Effectiveness Data) in preparation for modular PMA (Premarket Approval) and PSA (Performance Study Application) of class III IVD devices.
• Evaluated the quality and integrity of reported data and performed document revisions in preparation for PMA and PSA submissions
• Created technical documentation including protocols, reports, standard operating procedures, and testing plans.
• Provided technical support to marketing teams during product launches, addressing any concerns or questions regarding product specifications.
• Mentored junior scientists, fostering collaborative, productive work environment.
• Increased patent portfolio by filing multiple successful patent applications for novel inventions.

• Led the Leica Biosystems employee green team, at Danvers site and improved associate engagement
• Ensured sustainability is incorporated into product development tollgate process
• Monitored site use of energy, water, waste disposal, etc.

Responsible for delivering project revenues, and collaborating with multidisciplinary teams to drive project success.

• Collaborated with technical leads to author/revise study protocols and reports, relevant SOPs, and Work Instructions using templates, and example documents.
• Conceptualized and proficiently executed planned studies to accommodate dynamic and aggressive timelines, and presented findings at team meetings, and conferences, increasing visibility for the organization.
• Validated incoming data to check information accuracy and integrity while independently correcting concerns, and managed complex databases to ensure accuracy and accessibility of critical information.
• Leveraged advanced statistical techniques to analyze large datasets, uncovering trends and correlations relevant to research and development objectives.
• Managed DHFs (Design History Files), periodically reviewed and supported DHF audits to ensure device's design phase followed approved design plan and components serves user needs for which it is developed.
• Conducted comprehensive literature reviews to stay current on industry trends and emerging technologies (emerging biomarkers), to inform study designs and methodology decisions.
• Evaluated competitor products to identify potential areas for differentiation and improvements in Leica's offerings.
• Maintained accurate documentation of all technologies and experiments, facilitating seamless replication or future reference when needed.
• Provided extra coverage for the team in any unplanned absence of histo-technician by performing sample preparation, microtomy, and supplying adequate bond-ready slides.
• Collaborated with laboratory manager to develop new protocols, review existing protocols and procedures to initiate process improvements and make existing processes more efficient.
• Performed, and documented preventative maintenance of laboratory instruments, and collaborated with laboratory manager to ensure all equipment was calibrated to sustain high instrument performance and prevent abrupt instrument failure.
• Implemented safety protocols within the lab, ensuring compliance with regulatory guidelines and minimizing potential hazards.

Responsible for developing strategies for dip coating Polydimethylsiloxane (PDMS) catheters to intermittently release nitric oxide.

• Optimized experimental procedures through rigorous testing and troubleshooting efforts, reducing errors in result interpretation.
• Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
• Developed comprehensive reports on research progress, keeping stakeholders informed and engaged.
• Managed laboratory equipment and resources, ensuring proper maintenance and optimal functionality.

Worked strategically to increase awareness, sales, and use of company's products.

• Established strong relationships with healthcare professionals, resulting in increased trust and credibility for organization.
• Implemented effective follow-up protocols, ensuring timely responses to customer inquiries and concerns.
• Monitored inventory levels proactively, mitigating potential shortages or surpluses before operations or customer satisfaction are impacted.

• Supported course instruction through leading breakout sessions, group discussions, and supplementary lessons designed to reinforce key concepts.
• Handled and cared for laboratory animals (mice, rabbits, and Wistar rats), dosing (dose conversion between humans and animal models), and administration (oral, intraperitoneal, intramuscular).