Scientist III – Assay Development

Position Summary.

The Scientist III – Assay Development will work as part of Nuclein’s Assay Development organization, 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 lab. The individual will work within design control and scientific methods to conduct experimental studies in support of design, development and commercialization of Nuclein’s assay products. 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 assay.

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

·          Author SOPs, study protocols and study reports.

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

·          Work closely with the company’s Research division, providing integration support for new, and 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.

·          5-7 years of combined, hands-on laboratory working experience in essential technical areas required. The essential technical areas include quantitative PCR, nucleic acid extraction from biological specimens, or microbiological culture.

·          2 years of experience in preparing and execution of molecular assay V&V studies for 510(k)/EUA/CE-IVD submissions required.

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

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

·          Working experience in QC method development, risk management preferred.

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

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

THIS POSITION IS 100% ONSITE IN AUSTIN, TX. CANDIDATES MUST CURRENTLY LIVE WITHIN COMMUTING DISTANCE TO BE CONSIDERED. NO SPONSORSHIP IS BEING OFFERED AT THIS TIME.