Summary
Overview
Work History
Education
Skills
Accomplishments
Publications
Timeline
Generic

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, WI
12.2010

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
Katie Ballenger