We are seeking a motivated, bright, proactive individual who is highly detail-oriented and interested in joining the team in developing and supporting innovative diagnostic tests that advance patient care in inflammatory bowel disease (IBD), metabolic dysfunction-associated steatohepatitis (MASH), and other autoimmune and liver diseases.
SUMMARY Contributes to the design, development, optimization, analytical validation, transfer, and post-launch support of diagnostic assays. Independently executes assigned scientific studies, analyzes results, troubleshoots complex technical issues, and recommends solutions while collaborating with scientists and cross-functional teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Plan, execute, analyze, and document assigned assay development, feasibility, optimization, verification, and analytical validation studies with general guidance.
- Own defined technical workstreams, including experimental plans, data quality, project milestones, and timely communication of risks.
- Develop and optimize assay workflows, reagents, calibrators, controls, and automated instrumentation methods; evaluate assay performance and robustness.
- Investigate unexpected results and troubleshoot assay, reagent, specimen, and instrumentation issues; propose and test corrective actions.
- Analyze experimental and quality-control data using appropriate statistical tools and make evidence-based recommendations.
- Author and revise study protocols, SOPs, technical reports, validation documents, investigations, and laboratory records.
- Support assay transfer and implementation into the clinical laboratory, including training, post-launch monitoring, maintenance, and troubleshooting.
- Collaborate with TechOps, Clinical Laboratory Operations, Manufacturing, and other groups to support product readiness and compliance.
- Evaluate new technologies and process improvements and present scientific findings to project teams and management.
- Provide hands-on technical guidance to junior colleagues as appropriate; comply with applicable CAP/CLIA requirements, quality procedures, and laboratory safety guidelines.
SUPERVISORY RESPONSIBILITIESThis job has no supervisory responsibilities.
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCEPosition generally requires a BA/BS degree in the biological and life sciences with 2 years previous professional level experience and 4-6 years of product development and/or laboratory experience or a MS in the biological and life sciences with no previous professional level experience and 4-6 years of product development and/or laboratory experience. Demonstrated hands-on experience with immunoassays and/or molecular assays (e.g., ELISA, HPLC, SNP assays), reagent preparation, experimental design, data interpretation, and technical troubleshooting required. Experience with assay automation, analytical method validation, diagnostic product development, and CLIA/CAP or other regulated environments (GLP/GMP/FDA) preferred.
LANGUAGE/COMMUNICATION SKILLS Ability to read and analyze professional journals, technical procedures, and governmental regulations is required. Ability to write reports, business correspondence, procedure manuals, and SOPs. Ability to effectively present information and respond to questions.
MATHEMATICAL SKILLSAbility to apply mathematical concepts and operations to test reliability and validity of data. Proficiency in Excel is required.
REASONING ABILITYAbility to independently define technical problems, design appropriate investigations, critically evaluate data, identify root causes, and develop defensible conclusions.
CERTIFICATES, LICENSES, REGISTRATIONSNone required.
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 55 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.
