Method Validation Scientist - II LC-MS

LabcorpMadison, WI
Onsite

About The Position

We are seeking a Method Validation Scientist to support our Global Bioanalytical team in Madison, WI. This role involves organizing and performing method validation and testing with relative independence, ensuring compliance with SOPs and regulatory guidelines. The scientist will also provide downstream support, act as a bioanalytical resource, and contribute to process improvement initiatives. This position requires intermediate data interpretation and analytical instrumentation skills, with the ability to troubleshoot routine problems with minimal assistance. Responsibilities include reviewing reports, maintaining study documentation, and communicating effectively with colleagues and external clients. The role also involves training less experienced staff and maintaining a safe laboratory environment.

Requirements

  • Bachelor’s degree in a science related field (e.g. chemistry biology, molecular biology, immunology, biochemistry etc.)
  • 3 years or more experience in advanced laboratory scientific methods or scientific investigation
  • 3 years or more of experience in a regulated laboratory setting
  • 2 years or more in a GLP or GMP environment
  • 2 years or more working with Liquid Chroma LC-MS or Mass Spectrometer environment

Nice To Haves

  • 3 years or more Method Validation experience
  • 2 years or more Stability Testing
  • 3 years or more in a Bioanalytical Lab environment
  • 2 years or more in a Data Analysis environment and troubleshooting
  • Experience with laboratory automation software, (analyst, e-workbook, Nautilus, Sciex, OS)
  • Experience in laboratory conduct and data interpretation
  • Experience and proficiency with laboratory analytical instrumentation
  • Excellent communication and interpersonal skills with excellent attention to detail

Responsibilities

  • Organize and perform routine to moderate level of method validation/testing (and all associated activities) with relative independence and efficiency in compliance with appropriate SOPs and regulatory agency guidelines.
  • Execute advanced level of method validation activities with guidance.
  • Provide downstream support of methods to associated groups and serve as a bioanalytical resource to the broader business.
  • Display intermediate data interpretation and analytical instrumentation skills and work through procedural and scientific routine problems and issues with minimal assistance.
  • Assist in review of reports, methods, protocols, and SOPs and maintain complete study documentation in compliance with regulatory guidelines (e.g. GLP and GCP) and department processes.
  • Inform Lead Scientist and/or management of any problems and/or deviations that may affect integrity of the data; participate in corrective action of problems.
  • Manage work on assigned projects in a given week, and liaise and coordinate work activities with team members in order to deliver data (right first time) to internal clients.
  • Effectively interact with colleagues within Bioanalytical site.
  • Train, and assist less experienced staff.
  • Participate in process improvement initiatives.
  • Support communications with external clients and other team members.
  • Review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
  • Maintain a clean and safe laboratory work environment.
  • Perform other related duties as assigned.

Benefits

  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD
  • 401(k)
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan
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