Vimukthi (Vim) Senevirathne

• Routinely use innovative solutions to develop Molecular Diagnostic Assays (qPCR) to detect human bacterial and viral pathogens
• Highly experienced with Automated Liquid Handling and Molecular Diagnostic systems
• Use Project Management skills and work collaboratively with multiple Departments (QA, Regulatory, Clinical) to submit IVDR and 510(k) applications for Molecular Diagnostic Assays
• Taking project leadership roles, design experiments and manage small teams
• Collaborate, communicate effectively with other teams and foster creative problem solving to meet project deadlines

Projects:

• Product Development Lead Scientist supporting IVDR and 510(k) submissions for Epstein-Barr Virus (EBV) Assay
• Product Development Lead Scientist supporting the Whole Blood Matrix Extension project in Transplant Assays. Supported Clinical sites as the subject matter expert during clinical feasibility testing
• Lead Scientist supporting Project Foundation activities during re-development of Quality Control methods for the FluA/B, RSV, SARS-CoV-2 (4-Plex) Assay
• Continually supporting the Regulatory group during International Registrations of assays

• Led teams Cross-Functionally to develop Molecular Diagnostic assays to enhance company product portfolio
• Firsthand experience from assay design, optimization, assay integration (pilots and transfer) to manufacturing
• Applied Cross-Functional Leadership and Project Management skills to foster collaboration with multiple Departments (Manufacturing, Validations and Quality Control) to ensure timely completion of projects
• Set goals for the team, design experiments and ensure timely completion of the tasks
• Trained, mentored and managed team members and empowered the team to support day to day operations
• Applied creative problem solving during new product development and integration
• Troubleshot problems with existing products and assisted Technical Services and Manufacturing groups

• Implemented cutting-edge technologies and innovative thinking to develop Molecular diagnostic assays and Microbiological methods to detect foodborne pathogens
• Generated intellectual property by devising innovative solutions to complex problems, leading to patent applications and licensing opportunities
• Expertise in PCR, qPCR, RT-qPCR, Helicase Dependent Isothermal Amplification (HDA) and Nicking Enzyme based Isothermal amplification (NEAR) technologies
• Expertise in using a wide range of equipments (qPCR and Isothermal amplification systems, Lyophilizers, Liquid-handling systems, Spectrophotometers etc.)
• Expertise in performing DNA/RNA sequence alignments and designing primers and probes for qPCR and Isothermal amplification assays
• Provided in-sights, designed and conducted experiments to develop new products and expand the claims of the current products
• Continuously used innovative research skills and troubleshooting skills for new product development
• Recorded experimental results, analyzed data, provided research summaries, developed SMPs and SOPs and presented at R&D technical meetings
• Supervised junior technicians and scientists

Projects:

• Successfully developed an assay to detect Salmonella spp. In environmental samples (Patented)
• Participated in a successful Beta site customer study for the Salmonella spp. Assay as the Subject Matter Expert
• Played a crucial role in updating the molecular diagnostic platform (from NEAR to HDA) and started new external collaborations

• Developed of Molecular diagnostic assays and Microbiological methods to detect foodborne pathogens
• Expertise in PCR, qPCR, RT-qPCR, Helicase Dependent Isothermal Amplification (HDA) and Nicking Enzyme based Isothermal amplification (NEAR) technologies
• Evaluated new technologies for potential integration into existing research processes, driving continuous improvement efforts
• Streamlined laboratory workflows, resulting in reduced costs and increased productivity
• Continuously used innovative research skills and troubleshooting skills during new product development
• Championed knowledge sharing within the organization by organizing seminars, workshops, and training sessions

Projects:

• A member of the team that developed and obtained AOAC certification for the ANSR Listeria Right Now Assay
• Successfully introduced and validated amplicon removal function across different assay formats

Awards:

• Recognized as the Emerging Scientist of the Year during Neogen’s annual global R&D summit in 2019

• Routinely conducted quality research, published in high-impact peer-reviewed Journal articles to increase the reputation of the lab within the scientific community and helped with Grant applications to secure funding
• Initiated productive collaborations with other research groups that resulted in high-quality publications
• Presented scientific findings at multiple conferences and research summits
• Supported as a Teaching Assistant in multiple theory and lab classes ranging from Molecular Biology, Biochemistry and Organic Chemistry classes
• Obtained an honors Citation for Excellence in Teaching, Department of Chemistry, Wayne State University in 2013
• Managed the lab mouse colony and routinely performed setting up breeding pairs, weaning, tissue harvesting, genotyping, euthanasia, writing protocols and training personnel
• Lab Hiring Manager: Responsibilities involved conducting interviews, training, managing undergraduate student assistants, submitting bi-weekly time sheets and writing recommendations.