Emily Gilbreath Email & Phone Number

Greensboro, North Carolina, US

Greensboro, North Carolina, US

Greensboro, North Carolina, US

Greensboro, North Carolina, US

• Responsible for FDA corporate regulatory strategy and scientific defense of tobacco products with emphasis on product design, materials, and manufacturing processes. Accountable for corporate FDA portfolio risk.
• Successfully authored and published significant portions of 100+ FDA submission responses after collaborating with internal and external counsel
• Significantly reduced FDA submission response time by independently identifying, developing and implementing a comprehensive FDA tracking tool:o Utilized for over 300+ productso Executive approved and utilized for.
• As scientific affairs specialist on internal cross-functional Cigarette FDA Submissions Team in conjunction with Toxicological Defense Team, identified, developed, gained Executive Leadership approval, and successfully.
• Selected as an upcoming leader to attend pilot program for Emerging Leaders. Successfully presented observations and suggestions to Executive Leadership, which lead to program improvements

Bristol, Bristol, GB

• As part of the COMPASS Team, responsible for creating a new Central Systems foundation for all major product groups in all rest-of-world markets including the full implementation of our Bill of Materials module. Fully.
• Managed stakeholders from departments including Product Development, Compliance, Regulatory, Laboratory Testing, Procurement, Marketing, Factories, Print Development, and Master Data Management
• Streamlined product development sub-processes by creating a more LEAN and agile way-of-working through independently leading and implementing the Dashboard with ARAS
• Independently authored formal Requirements Documents and acted as a liaison to an outside consultant firm to implement and develop the Specification Management portion of a new Central System
• Functional Reviewer of Specification Management requirements to ensure successful and compliant implementation
• International liaison for ITG Brands and Reemtsma for transition to new Central System for future product groups

• As research assistant, responsible for conducting genomic and analytical processes to advance research in recombination and crossing-over. In addition, as genomic Subject Matter Expert (SME), responsible for training.
• Gained advanced knowledge through thesis work by levering scientific strengths in chemical engineering, molecular techniques, and analyzing large data sets
• Recognized as statistical SME in R, MEGA, PAML and BioEdit. Highly skilled in High Performance Liquid Chromatography (HPLC), Fourier transform infrared spectroscopy (FTIR), and UV spectroscopy
• Due to strengths in molecular techniques and interpersonal skills, sought by PhD candidates for one-on-one training to advance their research
• Continually achieved only high marks from students on anonymous performance evaluations in teaching style, leadership, and passion for the subject

Burlington, North Carolina, US

• Responsible for research and screening on possible bone marrow transplant recipients with emphasis in analytical practices. Responsible for reviewing and releasing genomic results to multiple outside clients with.
• High learning agility resulted in achieving proficiency in all relevant analytical and genomic procedures led to a 3-year promotion in 8 months
• Significant knowledge in Polymerase Chain Reaction (PCR), Sequence Specific Primers (SSP), Sequence Based Testing (SBT), Electropherograms
• Streamlined genomic and analytical practices by improving existing SOP decreasing turn-around-time for analytical results
• Selected and successfully led train incoming technologists for all analytical and genomic practices
• Achieved all identified quality, accuracy, and timeframe metrics for outside clients annually

Master Of Science (M.S.), Biology/Biological Sciences, General

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

Bachelor Of Arts (B.A.), Psychology