Method Validation Scientist - II LC-MS

About the role

Method Validation Scientist to support our Global Bioanalytical team in Madison, WI. Work Schedule: Monday – Friday (Day Shift).

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 site.
• 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.

Qualifications

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 Chromatography 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

Benefits

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.