Experience

Technopath Clinical Diagnostics

• Ireland
• Hospitals and Health Care
• 1 - 100 Employee

• Research and Development Project Manager

  • Jan 2022 - Present

  Major Responsibilities: Ensure that new product development projects products are conducted in compliance with applicable through the generation and maintenance of the requisite Design History Files. Assist in the development of design and process verification and validation test plans. Coordination of verification test protocols with SMEs and organisation of the evaluation and application studies relevant to new or existing IVD products. Liaise directly with Business Development and assess the information that is captured in the market relating to new product development and existing product improvement. Work directly with the Engineering and Production departments in relation to the scale up of existing products/processes and the transfer of new products/processes from R&D to Pilots to Commercial Lots to Stock. Responsible for ensuring that Design Control / R&D procedures are maintained and updated meeting regulatory requirements.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Scientist

  • Nov 2021 - Jan 2022

  MAJOR RESPONSIBILITIES: • Project Management: Independently design, manage, and conduct complex long duration projects, product improvements, and investigations (or supports Third Party Manufacturing projects). • Product and Process Improvements: Independently manage complex long duration projects, product improvements, and investigations. Recognizes opportunities and proposes novel ideas for significant operational, process or product improvements. Proactively identify opportunities for significant operational, process or product improvements. Perform or support test and process method modifications, considering CQAs, critical process parameters and analytical performance characteristics. Identify technical alternatives and make risk-based decisions within the area. Use technical data that interacts with multiple areas and processes. Provides diverse, independent technical data and insight to support risk management evaluation and assessment. • Design control and risk management: Effectively balances compliance risk and business risk to create and review risk management files. • Complaint and internal investigations: Independently manages complex investigations to resolution. Demonstrates advanced statistical techniques, MAIC and or project management tools. Provides audit inputs and support as required • Technical Support: Assist in resolution of multiple complex technical and quality issues across ADD Sites, TPMs and or functions (instrument; reagents; software and commodities). Anticipate, recognize and resolve technical issues. • Sharing Knowledge: Presents complex technical information to internal and external groups. Shares scientific information and expertise with customers and regulatory agencies. Experience mentoring and teaching others to facilitate timely resolution of product and process technical issues. • Strategic and Results Orientation: Translates top-level goals to specific goals and aligns activities with respective strategic business priorities.



H3 Biomedicine

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist

  • Jul 2019 - Jan 2022



RTA Laboratories

• Production Manager

  • Jun 2016 - May 2017



Istanbul University

• Türkiye
• Higher Education
• 700 & Above Employee

• Researcher Phd Candidate

  • 2011 - Apr 2016

  Thesis Title: The effect of phenolic and flavonoid substances in propolis, on cell cycles pathway in MCF7 and MCF10a breast cancer cell lines. Techniques used: -Cell Culture -Apoptosis analysis using Flow Cytometry -Proliferation Assay (WST1) -Whole Genome Expression Array -RNA Isolation and QC check using Bioanalyzer -Bioinformatics, Pathway Analysis Courses Thought -Pharmacogenetics -Molecular Pharmacogenetics Thesis Title: The effect of phenolic and flavonoid substances in propolis, on cell cycles pathway in MCF7 and MCF10a breast cancer cell lines. Techniques used: -Cell Culture -Apoptosis analysis using Flow Cytometry -Proliferation Assay (WST1) -Whole Genome Expression Array -RNA Isolation and QC check using Bioanalyzer -Bioinformatics, Pathway Analysis Courses Thought -Pharmacogenetics -Molecular Pharmacogenetics



DONE Genetics and Bioinformatik Inc.

• Laboratory Coordinator

  • Apr 2014 - Mar 2016