The Assay Development Scientist/Senior Clinical Technologist will work with a team of clinical scientists to develop and implement new mass-spectrometry based tests for the Toxicology and Biochemical Genetics sections of the Clinical Mass Spectrometry Laboratory. The Assay Development Scientist will use GC, LC/MS, GC/MS and ICP/MS platforms for analysis and quantification of drugs, hormones and metabolites for diagnosis and treatment of diseases. They will also contribute to maintaining the performance of the existing clinical tests and instruments in the clinical mass spectrometry laboratory.

In addition to performing the development and validation responsibilities, the assay development scientist with their high level of expertise, and with assistance from Medical Laboratory Scientists (Specialists and Senior) is responsible for and oversees the following activities in their area of expertise.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Technical Lead:

• Assist in the development and implementation of new clinical tests and selection of new equipment. 
• Perform validation of tests, equipment, analyzers, in mass-spectrometry area of expertise.
• Provide advanced problem solving, troubleshooting and verification of test results.  Acts as technical adviser/expert in area of expertise.
• Provide day-to-day technical direction of qualified personnel performing testing and reporting high complexity test results.
• Assists with reviewing, modifying, or archiving procedures and policies no less than biennially within the document management system. 
• Provides advanced problem solving, troubleshooting, interpretation, consultation, and verification of test results.  Acts as technical adviser/expert in area of expertise.
• Participate in inventory management and control, as needed.
• In collaboration with the manager, supervisor, and director communicate workflow and other changes specific to section.
• Participate in departmental safety meetings and audits.
• Responsible for providing coverage for call-ins during the week and weekends in absence of Supervisor.
• Acts as CLIA General Supervisor if assigned.

QC/QA/Compliance

• Monitor, organize, maintain quality control and quality Assurance Records.
• Ensure that quality assurance and control is performed in a timely manner. 
• Maintains all QA/QC records.
• Review Quality Control and instrument function reports to ensure that acceptable levels of analytical performance are maintained.
• Monitors instrument maintenance, repair, and calibration in area of expertise
• Assists in preparation for CAP inspections.
• Submits PT surveys and performs summary review, along with review with testing personnel.
• Monitor, improve, and implement corrective action for process improvement.
• Help create and manage QA program for section and participate in the lab QA program.

Training/Competency

• Conduct training and competency assessments for all new test methods or new equipment.
• Creates, maintain, and evaluate training plans and checklists.

Development and Validations

• Review scientific literature pertinent to the method(s) being developed
• Identify and refine extraction, chromatographic separation and mass spectrometry conditions for identification and quantification, as applicable of the desired analytes
• Develop validation plan(s) in collaboration with technical supervisor.
• Write the initial draft of the procedure(s) for implementation of newly validated tests.
• Present updates on the progress of the development and validation process and maintain communication throughout the process

Perform Testing for Waived, Moderate, and High Complexity Tests

• Perform and document quality control and proficiency testing for waived, moderate, and high complexity tests. 
• Act on out-of-range quality control values.
• Perform waived, moderate, and high complexity testing.
• Analyze patient samples and report test results consistent with accuracy and quality assurance goals of the laboratory into laboratory databases.
• Interpret test results for waived, moderate, and high complexity tests.

Professional Development

• Fulfill departmental continuing education requirement, as applicable.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Regular duties include:

• Develop and validate clinical laboratory tests performed by mass-spectrometry
• Perform duties of Medical Laboratory Scientists.
• Identify problems with instrumentation, methodology, specimens, supplies, or results and act as outlined in predetermined protocols.
• Update procedure manuals and training materials to reflect current practices
• Serve on laboratory and inter-departmental committees as requested
• Initiate corrective action when required.
• Maintain a safe work area in a well-stocked, clean condition.

In order to be considered for this position the applicant must have met or will have met all the required qualifications prior to the start date of employment.

• Bachelor of Science degree in Medical Laboratory Science, or biological science that is directly related to the duties of the position is required.
• Previous GC, LC/MS instrumentation experience.
• Previous toxicology, endocrinology or biochemical genetics and/or IVD assay development experience.
• Must have demonstrated ability to perform the duties of an MLS at a high level of expertise, and the ability to perform the assigned work without sacrificing patient care or assigned work.
• Must have the demonstrated ability to communicate clearly, concisely, and effectively with other medical personnel in both verbal and written form; demonstrated ability to independently organize and prioritize work, and to exercise initiative in recognizing and solving problems. Demonstrated ability to work effectively with a diverse team.

• Master's degree or above in biological science with minimum three years mass spectrometry experience
• Time management skills and the ability to accomplish extra duties while completing patient work

This full time, 40 hour position is on the day shift and will require rotating weekends, holidays and on-call schedule.

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

• Works with infectious disease and/or hazardous materials.
• May have exposure to noise from laboratory equipment and pneumatic tube system.
• Requires frequent (standing/walking/sitting/hand pipetting) for long periods of time and the ability to lift to 25 lbs. 

This position is included in the bargaining unit represented by the United Michigan Medicine Allied Professionals (UMMAP), which represents bargaining unit members in all matters with respect to wages, benefits, hours, and other terms and conditions of employment.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal opportunity/affirmative action employer.