Scientist III - Assay Development

Position Summary.

The Scientist III – Assay Development will work as part of Nuclein’s Assay Development, reporting to the Vice President of Assay Development. This is a hands-on laboratory scientist role, expecting up to 75% of the time spent in the laboratory. The individual will work within design control principles and scientific methods conducting studies to support the design, development and commercialization of Nuclein’s IVD assays. The Scientist III will serve as the Subject Matter Expert and provide technical leadership in at least one technical or design assurance area applicable to IVD assay development.

Essential Duties and Responsibilities. 

·          Adhere to Good Laboratory Practice (GLP) guidelines in 21 CFR Part 58 (FDA, DHHS) relevant to Nuclein’s laboratory activities.

·          Adhere to Nuclein’s design control, Good Documentation Practice (GDP) and quality system procedures.

·          Design studies and create study protocols for the development and verification of IVD assays.

·          Lead the execution and reporting of development and verification studies.

·          Support development of assay design specifications, product specifications, BOM and manufacturing procedures.

• Work closely with the company’s Research division, providing as needed support for new or existing assays.

·          Work with general molecular biology and microbiology laboratory equipment, biological specimens, reagents and chemicals.

·          Maintain a safe, organized, and efficient work area following laboratory SOPs.

·          Support assay QC method development, spec setting and guard banding activities.

·          Support clinical trial activities.

·          Other duties as assigned.

Education, Qualifications, and/or Experience. 

·          Bachelor’s degree in biological sciences, biotechnology, or related technical field, or equivalent years of combined education and experience required. Master’s degree or higher in a related technical field preferred.

·          9 years of combined, hands-on laboratory experience in essential technical areas, including quantitative PCR, nucleic acid extraction from biological specimens, and/or microbiology.

·          2+ years of experience in preparing and executing molecular assay Verification & Validation studies for 510(k) submissions.

·          Familiarity working with sample-to-results IVD tests targeting infectious diseases a plus.

·          Strong analytical and problem-solving skills, with the ability to design scientific experiments, analyze and interpret complex data sets and draw meaningful conclusions.

·          Ability to write scientific and/or technical documents, such as experiment plans, protocols and reports.

·          Working experience in QC method development and risk management.

·          Experience with JMP, MATLAB, or other software tools used for analyzing large datasets.

Physical Requirements.  

·          Repetitive Motion: Mostly laboratory equipment such as a pipetter and computer use

·          Use of PPE is required in the laboratory

·          Weight Lifting: < 25 lbs

·          Position: sitting and standing