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
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
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
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
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
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
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
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