Philip Brady
Clondalkin,Ireland
Summary
Highly accomplished, results-driven Molecular Diagnostics & CPI Scientist with a First-Class Honours degree in Bioanalytical Science and over 10 years of robust industry experience within the In-Vitro Diagnostics (IVD) sector. Proven track record of managing complex projects from concept to commercialization, including spearheading cross-functional design verifications and international transport stability studies. Formally stepped into project leadership roles, coordinating with global stakeholders in France to secure high-stakes FDA (US) and China market approvals for diagnostic coagulation tests. Deep technical expertise across molecular biology platforms (PCR, RT-PCR, LAMP) and specialized hemostasis analyzers. Seeking a permanent senior scientific or project leadership position within a stable clinical or medical device organization to facilitate long-term growth and mortgage approval.
Overview
11
11
years of professional experience
Work history
CPI Scientist (Project & Team Lead)
Tcoag Ireland Ltd
Bray, Co. Wicklow
2023.08 - 2026.05
- Global Regulatory Leadership: Coordinate seamlessly as the functional Team Lead alongside stakeholders in France to drive data verification required for complex FDA and China market approvals of IVD coagulation tests.
- Study Design & Execution: Plan, execute, and author comprehensive protocols and detailed final reports for multi-variable transport stability studies.
- Advanced Data Analytics: Conduct rigorous statistical analysis using Analyse-it and Minitab software to interpret and validate critical study data for regulatory audits.
- Clinical Testing: Operate complex hemostasis analyzers to run testing on patient plasma samples and controls, ensuring absolute accuracy and repeatability of results.
- Cross-Functional Alignment: Work closely with Quality and Regulatory departments to safeguard international compliance frameworks including ISO 13485, US FDA 21 CFR part 820, and IVD Directive 98/79/EC.
- Contract concluding August 2026
R&D Scientist (Molecular Diagnostics)
Hibergene Diagnostics
2015.06 - 2022.08
- Product Delivery: Pivotal member of the core R&D team that successfully designed, validated, and brought 10 distinct diagnostic products to market from early design conception straight through to large-scale commercial launch.
- Regulatory Success: Executed rigorous validation and testing protocols that directly contributed to achieving CE Marks in Europe and FDA approvals for global distribution.
- Assay Innovation: Developed and optimized robust molecular assays utilizing PCR and LAMP technologies under tight deadlines.
- External Auditing & GMP: Performed manufacturing site-visits to UK partners ensuring compliance with technical specifications, reviewing manufacturing batch records, and drafting critical internal SOPs.
Education
B.Sc. (Honours) - Bioanalytical Science
Technological University Dublin
TallaghtBachelor of Science - Bio Analysis
Technological University Dublin
TallaghtHigher Certificate - Science in Applied Biology
Technological University Dublin
TallaghtSkills
- Project Leadership & Market Access: Cross-Functional Project Management, Global Stakeholder Management (US, France, China), Regulatory Submissions Strategy
- Molecular Diagnostics & IVD: LAMP Assays, qPCR, RT-PCR, Formulation Optimization, Experimental Design, Hemostasis Analyzers, Patient Plasma/Control Handling
- Data Analysis & Software: Statistical Analysis, Data Mining, Minitab, Analyse-it, SAGE Software (Inventory Control)
- Quality & Regulatory Compliance: ISO 13485, US FDA 21 CFR Part 820, IVD Directive 98/79/EC, IVDR, Good Manufacturing Practices (GMP)
REFERENCES
Excellent references available upon request from both industry supervisors and executive management
Timeline
CPI Scientist (Project & Team Lead)
Tcoag Ireland Ltd
2023.08 - 2026.05
R&D Scientist (Molecular Diagnostics)
Hibergene Diagnostics
2015.06 - 2022.08
Bachelor of Science - Bio Analysis
Technological University Dublin
Higher Certificate - Science in Applied Biology
Technological University Dublin
B.Sc. (Honours) - Bioanalytical Science
Technological University Dublin