Method Validation Scientist - LCMS

Labcorp•Madison, WI

1d•Onsite

About The Position

Method Validation Scientist to support our Global Bioanalytical team in Madison, WI. Work Schedule: Monday – Friday (Day Shift) Method Validation Scientist – LCMS Job Responsibilities: In this role, you will perform method validation, method update and stability testing using LCMS in compliance with standard operating procedures (SOPs) and regulatory agency guidelines. You will also provide downstream support of methods to associated groups. Serves as a bioanalytical resource to the broader business. Organize and perform routine method validation testing (and all associated activities) with relative independence and efficiency in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines. Capable of executing advanced level of method validation activities with guidance. 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 accurate data 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.

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
2 years or more of experience in a regulated laboratory setting
1 year or more in a GLP or GMP environment
1 year or more working with Liquid Chromatography and or Mass Spectrometer environment

Nice To Haves

1 year or more Method Validation experience
1 year or more Stability Testing
1 year or more in a Bioanalytical Lab environment
1 year or more in a Data Analysis environment and troubleshooting
Experience with of 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

Perform method validation, method update and stability testing using LCMS in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.
Provide downstream support of methods to associated groups.
Serve as a bioanalytical resource to the broader business.
Organize and perform routine method validation testing (and all associated activities) with relative independence and efficiency in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines.
Execute advanced level of method validation activities with guidance.
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 accurate data 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.