Nicole J. Burns Email & Phone Number

• Expert in the analysis, interpretation, and reporting of germline variants identified by clinical whole genome sequencing (WGS) through the Illumina Laboratory Services group, a CLIA-certified, CAP-accredited laboratory.
• Executed all aspects of clinical case management and analysis, including medical records review and phenotyping, variant triage and prioritization, variant and gene curation, case analysis review, and clinical report.
• Performed curation… Show more Expert in the analysis, interpretation, and reporting of germline variants identified by clinical whole genome sequencing (WGS) through the Illumina Laboratory Services group, a.
• Performed curation, interpretation, and classification of single nucleotide variants (SNVs) and small indels in nuclear and mitochondrial genes, copy number variants (CNVs), short tandem repeats (STRs), and.
• Co-developed internal criteria for applying ACMG or ClinGen guidelines to variant classifications, resulting in more consistency in variant interpretation and classification across the team.
• Curated content for pharmacogenomics (PGx) clinical reports following CPIC guidelines.

Scientific consulting to Illumina through ProUnlimited.

• Managed design-controlled medical device product development projects for this innovator in medical aesthetics.
• Managed class III medical device development projects, including new product developments and product line extensions.
• Led efforts of R&D, manufacturing, quality, regulatory, and clinical affairs personnel through successful pivotal clinical trial, FDA submission, and manufacturing scale-up activities for a new medical device.
• Coordinated clinical protocol developments… Show more Managed design-controlled medical device product development projects for this innovator in medical aesthetics.
• Coordinated clinical protocol developments and IDE regulatory submission preparations in pursuit of new clinical indications for existing medical devices.
• Initiated and planned project to launch an existing medical device in the Chinese market, including coordination with international colleagues to determine project strategy and contract with CRO for local regulatory.

• Managed all aspects of the design-controlled phase-gate product development process. Functioned as project manager, technical lead, and supervisor of a team of scientists, for this innovator, manufacturer, and supplier.
• Successfully led cross-functional project teams to launch twelve microarray reagent products within time and budget constraints.
• Led project to develop reagents for a microarray-based… Show more Managed all aspects of the design-controlled phase-gate product development process. Functioned as project manager, technical lead, and supervisor of a.
• Led project to develop reagents for a microarray-based in-vitro diagnostic (IVD) assay to gain entry into medical device market.
• Co-created Roche NimbleGen’s Design Control System for product development, introducing project organization, accountability, and improved compliance within the firm’s quality system.
• Partnered with quality department to establish Roche NimbleGen’s first stability testing program to increase the accuracy of product shelf life and stability claims.

• Provided research support for three small laboratories within this large public university.
• Managed all aspects of set-up and maintenance for a new research laboratory, including ordering and calibrating equipment and supplies, writing protocols and safety documents, and ensuring laboratory members received.
• Managed day-to-day functions of laboratory and small-scale greenhouse.
• Supervised, mentored, and trained team members on laboratory techniques and safety… Show more Provided research support for three small laboratories within this large public university.
• Supervised, mentored, and trained team members on laboratory techniques and safety procedures.
• Executed various molecular biology techniques in support of the research goals of the principal investigators. Show less

• Performed genetic modification of soybean and cotton to support new product development for this former Fortune 500 agriculture biotechnology company.
• Co-led new automation technology implementation effort.
• Helped improve and streamline procedures for plasmid transformation and preparation, and inoculation preparation; reduced costs and improved results.
• Performed plant tissue culture using sterile techniques and executed molecular biology techniques.
• Created, reviewed, and… Show more Performed genetic modification of soybean and cotton to support new product development for this former Fortune 500 agriculture biotechnology company.
• Created, reviewed, and edited standard operating procedures (SOPs). Show less

M.S., Biotechnology

M.S., Project Management

B.S., Entomology