Associate Scientist II
About The Position
The Associate Scientist II contributes to the design, development, optimization, analytical validation, transfer, and post-launch support of diagnostic assays. The role independently executes assigned scientific studies, analyzes results, troubleshoots complex technical issues, and recommends solutions in collaboration with scientists and cross-functional teams. The work supports innovative diagnostic tests for inflammatory bowel disease (IBD), metabolic dysfunction-associated steatohepatitis (MASH), and other autoimmune and liver diseases. The position plans and documents assay studies, owns defined technical workstreams, develops assay workflows and evaluates performance, and supports assay transfer into the clinical laboratory. It also involves preparing technical and quality documentation, collaborating with operational and manufacturing groups, and following applicable CAP/CLIA requirements, quality procedures, and laboratory safety guidelines. This position has no supervisory responsibilities.
Requirements
- BA/BS degree in biological and life sciences with 2 years of previous professional-level experience and 4–6 years of product development and/or laboratory experience; or an MS in 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).
- Experience with reagent preparation, experimental design, data interpretation, and technical troubleshooting.
- Ability to read and analyze professional journals, technical procedures, and governmental regulations.
- Ability to write reports, business correspondence, procedure manuals, and SOPs, and to present information and respond to questions effectively.
- Ability to apply mathematical concepts and operations to test data reliability and validity; proficiency in Excel.
- Ability to independently define technical problems, design investigations, critically evaluate data, identify root causes, and develop defensible conclusions.
- Meet the physical demands described, including occasionally lifting and/or moving up to 55 pounds.
Nice To Haves
- Experience with assay automation, analytical method validation, diagnostic product development, and CLIA/CAP or other regulated environments (GLP/GMP/FDA).
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
