Method Validation Scientist - II LC - MS

Work Schedule

Monday – Friday (Day Shift). This position is 100% onsite in Madison, WI.

Job 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.
• Capable of executing 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.
• Displays intermediate data interpretation and analytical instrumentation skills and works through procedural and scientific routine problems and issues with minimal assistance.
• Assists in review of reports, methods, protocols, and SOPs and maintains complete study documentation in compliance with regulatory guidelines (e.g. GLP and GCP) and department processes.
• Informs Lead Scientist and/or management of any problems and/or deviations that may affect integrity of the data; participates in corrective action of problems.
• Manages 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 interacts with colleagues within Bioanalytical sites.
• Trains, and assists less experienced staff.
• Participates in process improvement initiatives.
• Supports communications with external clients and other team members.
• Able to review work of others for overall accuracy, timeliness, completeness, and soundness of technical judgment.
• Maintains a clean and safe laboratory work environment.
• Performs other related duties as assigned.

Minimum Qualifications

• 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-MStography and or Mass Spectrometer environment

Preferred Qualifications

• 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

Additional Job Standards

• 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