Assay Integration Scientist

Location

Ann Arbor, MI | United States

Job description

Summary

An Assay Integration Scientist position is available immediately with NeuMoDx™. As a member of the Assay Integration team, you will work cross-functionally to solve critical problems associated with the integration of individual molecular assays, hardware modules, and software components onto a complete clinical diagnostic system. Specific responsibilities will include development and execution of test protocols and verification/validation tests to evaluate and troubleshoot the performance of complex interactions between nucleic acid extraction methods from multiple clinical matrices, real-time PCR amplification and detection, and mechatronic modules – including thermal control modules, fluorescence detection modules, precision motion control elements and advanced liquid handling systems. The ideal candidate will have excellent background in molecular biology/biochemistry as well as moderate experience with the testing and integration of complex systems. We are looking for a well-rounded candidate with a knack for problem solving in both team and independent settings to ensure the completion of aggressive project timelines.

Position Responsibilities

Independently design, execute and troubleshoot nucleic acid purification, PCR amplification and real-time detection experiments.

Migrate bench-scale techniques into fully automated procedures run on the NeuMoDx™ platform, incorporating the assay chemistry, individual modules, liquid handling, and software interface.

Design, develop and execute test procedures for integration, validation and verification studies.

Identify, confirm, and interpret instrument performance issues related to integration of individual assays and mechanical modules. Communicate issues cross-functionally and provide suggestions, solutions, and/or test plans for resolution.

Participate in design review meetings and critically evaluate design and/or implementation plans.

Understand the requirements of the end-user and provide feedback regarding process or system improvements accordingly.

Maintain accurate data records, test plans, and reports. Clearly summarize and present information to senior management and other personnel both internally and externally as required.

Comply with document control procedures and maintain the effectiveness of the quality system.

Comply with biohazard safety standards through proper handling of potentially infectious biological agents and other hazardous chemical materials.

Essential Knowledge and Skills

B.S or M.S. in Biochemistry, Microbiology, Molecular Biology or related field with at least 2 years of relevant work experience, ideally in the in-vitro diagnostic industry.

Hands-on experience with current nucleic acid isolation and purification strategies.

Familiarity with design, development, verification and validation of molecular procedures and/or instrumentation.

Experience handling a variety of clinical specimens and pathogenic organisms.

Excellent written, verbal and analytical skills.

Ability to thrive in a challenging, fast-paced multidisciplinary setting.

Demonstrated problem solving skills to understand and solve complex, interrelated issues between assay chemistry, reagents, consumables, hardware, and software.

Strong proficiency in the use of MS Office Suite for data analysis and presentation; basic statistics knowledge is highly desired.

Knowledge of GLP, ISO, and QSR requirements for IVD products.

Experience

Nucleic Acid Extraction: 1 year (Required)

Assay Development: 2 years (Required)

PCR: 2 years (Required)

Education

Bachelor’s (Required)

Work authorization

United States (Required)

Required travel

25% (Preferred)

Job tags

Salary