Scientist I, Process Development

Location: 2910 Fortune Circle West, Suite E, Indianapolis, Indiana, United States of America


  • Lead process development initiatives in a regulated environment focused on sample preparation/preanalytical activities associated with biofluid processing (primarily blood), PBMC isolation, DNA/RNA extraction, and various forms of sample aliquoting
  • Develop, test, validate, and train new and improve existing methods.
  • Work with automation team to design, test, and validate new/improved automation methods
  • Design fit-for-purpose validations based on client needs
  • Proactively recommend process improvements
  • Draft/modify SOPs and validation documents for new and improved processes
  • Assist with project deliverables as needed

Qualifications (knowledge, skills, experience, abilities, and other requirements):

  • M.S. with 4+ years of industry experience, P.h.D. with 2+ years of industry experience
  • Must have experience working in a regulated environment (GxP, GLP, GCP, CLIA/CAP, etc)
  • Must have experience developing and validating methods in a regulated environment
  • Experience with handling blood, aseptic technique, and/or various forms of nucleic acid extraction highly desirable
  • Experience working with and comfortable around automation
  • Results-driven, go-getter who is a strong individual contributor but also operates well across teams

EOE  M/F/Disabled/VET