Katie Ballenger
Monona,Wisconsin
Summary
Experienced assay development scientist of complex multiomics and NGS-based projects. Responsible for leading design transfer of optimized reagents, workflow, and formulations from concept to final product, along with functionally managing a team of scientists. A dedicated people manager of multiple direct reports, tasked with technical leadership of multiple project components.
Overview
14
14
years of professional experience
Work History
Lead Scientist
Exact Sciences Corp
Madison, WI
02.2024 - Current
- Managed several complex projects in parallel to meet Operations Readiness goals for successful product launches.
- Led the design and development of IVD, LDT, an RUO manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines.
- Led activities to support process validation and launch readiness and execution. Led troubleshooting and root cause analysis investigations to resolve issues that arose during development manufacturing.
Senior Scientist
Illumina
Madison, WI
04.2022 - 12.2023
- R&D reagent development lead, responsible for team's delivery of all final formulations, guard-banding, stacked tolerance, fill volumes, stability, and specifications.
- Managed and professionally developed multiple direct reports at junior and mid-scientist levels. Team responsible for on-time delivery of critical project deliverables and meeting all ISO13485 QMS requirements.
- Responsible for Assay development and characterization of NGS-based methods, including short read WGS, enrichment, ctDNA, and proteomics-based solutions.
- Extensive experience as a developer and SME in analytical methods for formulation QC of critical components.
Scientist 1 & 2
Illumina
Madison, WI
09.2020 - 04.2022
- Managed daily operations of the research lab for RUO product development using ISO13485 QMS.
- Developed and led design transfer of bespoke QC assays for new product introduction from R&D to the sustaining QC teams.
- Led daily activities and experimental planning of multiple summer interns through Illumina's iAspire program.
Associate Scientist 1 & 2
Illumina
Madison, WI
01.2017 - 09.2020
- Assisted in troubleshooting and resolving complex technical issues.
- Assisted in training new laboratory personnel in lab procedures and safety protocols.
- Chartered the creation and implementation of a 6S environment in the R&D lab at Illumina-Madison.
- Conducted experiments in laboratory environment for product development purposes.
Research Associate 2
Illumina
Madison, WI
01.2016 - 01.2017
- Executed experimental test plans with senior members of the product development team.
- Owned project sub-tasks with guidance.
- Gathered, arranged, and analyzed experimental data to create representative graphs and charts highlighting results for presentations within the product development department.
Research Technician 2
Stanford University, HHMI
Palo Alto, CA
01.2011 - 10.2015
- Independently planned research strategies and organized tasks as well as troubleshot research projects as needed.
- Used molecular biology techniques involved in molecular cloning to carry out design and construction of reporter gene constructs to validate genomic data (RNA-seq, ChIP-seq).
- Supervised two undergraduate students in lab maintenance tasks as well as research projects.
Education
Bachelor of Science - Molecular Biology
University of Wisconsin - Madison
Madison, WI12.2010
Skills
- Technical Leadership
- Product Development Process
- Risk Management
- NGS
- Project Management
- Process Improvement
Accomplishments
Relevant Project Contributions
- Reagent and design transfer lead of Illumina's flagship proteomics solution
- Reagent and design transfer lead for cell-free circulating tumor DNA library prep kit
Successful Product Launches:
- Illumina DNA PCR Free, 2021 (Revenue to date: $14.1M)
Publications
- Bruinsma, S., Burgess, J., Schlingman, D. et al. Bead-linked transposomes enable a normalization-free workflow for NGS library preparation. BMC Genomics. 2018.
- J. Adrian, J. Chang, C.E. Ballenger, B. Bargmann, O.S. Lau, K.A. Davies, J. Alassimone, M. Rowe, K. Birnbaum, D.C. Bergmann. Transcriptome dynamics of the stomatal lineage: birth, amplification and termination of a self-renewing population. Developmental Cell. 2015.
- O.S. Lau, K.A. Davies, J. Chang, J. Adrian, M. Rowe, C.E. Ballenger, D.C .Bergmann. Direct roles of SPEECHLESS in lineage specification, asymmetric cell division, and hormone regulation during stomatal initiation. Science. 2014.
Timeline
Lead Scientist
Exact Sciences Corp
02.2024 - Current
Senior Scientist
Illumina
04.2022 - 12.2023
Scientist 1 & 2
Illumina
09.2020 - 04.2022
Associate Scientist 1 & 2
Illumina
01.2017 - 09.2020
Research Associate 2
Illumina
01.2016 - 01.2017
Research Technician 2
Stanford University, HHMI
01.2011 - 10.2015
Bachelor of Science - Molecular Biology
University of Wisconsin - Madison