Katy Rommel, Phd Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Raleigh, North Carolina, United States

• Client-facing representative of Kymanox technical project teams with overall accountability for project execution and success. Leader of both internal and external technical product and process development projects.
• Facilitate planning and execution of medical device and pharmaceutical product and process development-related activities ensuring completion of projects on schedule and within budget. Delegate and monitor quality and.

Raleigh-Durham-Chapel Hill Area

Raleigh-Durham, North Carolina Area

• DHF remediation for combination products.
• Reviews and provides input on areas of subject matter expertise, including study protocol design, acceptance criteria definition, and statistical data analysis.
• Writes study protocols and reports to support medical device regulatory filings.
• Provides technical project leadership, including management of schedule, budget, support staff, and project execution.

San Francisco Bay Area

• Led Zika system and assay integration troubleshooting programs for 7 months; daily cross-functional meetings, root cause analysis, design of experiments, quality control, bug identification.
• Improved quality of work from assay development team by instituting processes and appreciation for robust critical review of data and laboratory practices.
• Delivered weekly presentations on Zika project status to executive leadership to provide clear and concise updates and drive product strategy.
• Improved team morale and motivation during difficult times by providing regular communication from executive team to R&D team members as well as advocating from the bottom up.
• Directed a team of 7 Molecular Assay R&D scientists and 3 System Integration engineers.
• Defended Assay Development team in TÜV SÜD ISO 13485 Audit.

Palo Alto, CA

• Coordinated an 8 month multi-instrument clinical trial in collaboration with a hospital research laboratory that demonstrated the analytical and clinical performance of 4 lipids assays on a prototype clinical analyzer.
• Built the first MS Project integrated timeline to track cross-functional activities of 14 teams involved in the Zika product development lifecycle.
• Informed executive strategy to define product requirements based on in-depth market research and intimate knowledge of technological limitations.
• Established lunch meetings between R&D staff and executives to foster a positive team psychology and enable cross-level communication.
• Managed a team of 6 Chemistry Assay R&D scientists and 4 System Integration engineers.

• Created technical materials for a special session presentation at the 2016 meeting of the American Association for Clinical Chemistry (AACC), including presentation slides and technical video editing.
• Organized assay feasibility data from prototype clinical analyzers across 4 disciplines and evaluated quality of results with legal review.

San Francisco Bay Area

• Designed a semi-automated test system to run Chem 18 assays on capillary whole blood samples collected in a prototype collection device; including in-house formulated reagents and TECAN Freedom EVO automated liquid.
• Conducted early feasibility testing of clinical chemistry assays on a prototype clinical analyzer.
• Conducted early feasibility testing of activated partial thromboplastin time (aPTT) and prothrombin time (PT) feasibility on TECAN Freedom EVO automated liquid handling platform and a prototype clinical analyzer.

• Identified and characterized the indanomycin biosynthetic gene cluster in S. antibioticus using bioinformatics and stable isotope-labeled precursor incorporation studies.
• Disrupted an enigmatic gene in the indanomycin biosynthetic gene cluster and identified a previously unknown linear biproduct of the pathway.
• Cloned biosynthetic genes, expressed enzymes, synthesized probes, and assayed the in vitro kinetics of the last hydrolysis step to release indanomycin from the biosynthetic system.
• Cloned large polyketide synthase subunits and synthesized biosynthetic analogs to probe the mechanism of cyclization used to produce the indane ring structure.
• I use a number of techniques including bacterial cell culture, extraction, purification of small molecules from complex mixtures, organic synthesis, molecular cloning, bioinformatic analysis, protein purification, and.
• As a founding member of the Kelly lab, I gained valuable experience in building and maintaining a laboratory from the ground up.

Supervised and taught laboratory sections of General Chemistry and Synthetic Chemistry 1 and 2. Assisted teaching in lecture sections of Organic Chemistry 1 and 2 and Biochemistry 1 and 2. Responsibilities included organizing and leading review sessions, holding weekly office hours, and grading assignments.

Phd, Chemistry, 3.75

Activities and Societies: Women in Chemistry, Research Experiences for Undergraduates (REU) Mentor, Graduate Student MentorCharacterized.

Ba, Chemistry, 3.6

Honors in Undergraduate Research Glaxo-Smith-Kline Women in Science Scholar

Bs, Biology, 3.6