Nuclein, LLC
Scientist III
Nuclein, LLC, Austin, Texas, us, 78716
Job Title:
Scientist III – Assay Development
Department:
Assay Development
Position Summary:
The Scientist III -- Assay Development position will work as part of the Nuclein Assay Development organization, reporting to the VP of Assay Development. The individual will work independently within design control and scientific methods to design and perform experiments and tests necessary for the design, development, commercialization and support of assay products and related products.
Essential Duties and Responsibilities:
Support the assay development efforts from conception through to FDA 510(k) submission.
Independently design and execute experiments especially quantitative RT-PCR assays and sample preparation.
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.
Support development of reagent and material specifications, QC methods, BOM and manufacturing procedures.
Work with general molecular biology laboratory equipment, biological specimens, reagents and chemicals.
Maintain a safe, organized, and efficient work area following laboratory SOPs.
Troubleshoot and investigate failures related to assay reagents and other consumables.
Analyze experimental data and write study reports.
Education, Qualifications, and/or Experience:
Bachelor’s degree in biological sciences, or related technical field. Master’s degree or higher preferred.
Proficiency in molecular biology laboratory techniques required.
Proficiency in basic statistical methods required.
Experience with JMP, MATLAB, or other software tools used for analyzing large datasets preferred.
At least 3 years of laboratory experience in IVD assay development, or at least 6 years of laboratory experience in the field of molecular biology required.
Knowledge and hands-on experience in microbiology preferred.
Willingness to work in a BSL2 laboratory.
Ability to write scientific and/or technical documents, such as experiment plans, protocols and reports.
Ability to properly operate and maintain laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, real-time PCR instruments, biosafety cabinet, refrigerators and freezers.
General computer experience, e.g. Microsoft Office suite, and ability to use corporate data/document/project systems and operate/monitor test equipment.
Effective verbal and written communication with team members, scientists, engineers, and project managers.
Physical Requirements:
Repetitive Motion: liquid transferring pipetter and computer use.
Use of PPE required in laboratory/manufacturing/warehouse areas.
Weight Lifting:
Position: Mostly sitting.
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Scientist III – Assay Development
Department:
Assay Development
Position Summary:
The Scientist III -- Assay Development position will work as part of the Nuclein Assay Development organization, reporting to the VP of Assay Development. The individual will work independently within design control and scientific methods to design and perform experiments and tests necessary for the design, development, commercialization and support of assay products and related products.
Essential Duties and Responsibilities:
Support the assay development efforts from conception through to FDA 510(k) submission.
Independently design and execute experiments especially quantitative RT-PCR assays and sample preparation.
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.
Support development of reagent and material specifications, QC methods, BOM and manufacturing procedures.
Work with general molecular biology laboratory equipment, biological specimens, reagents and chemicals.
Maintain a safe, organized, and efficient work area following laboratory SOPs.
Troubleshoot and investigate failures related to assay reagents and other consumables.
Analyze experimental data and write study reports.
Education, Qualifications, and/or Experience:
Bachelor’s degree in biological sciences, or related technical field. Master’s degree or higher preferred.
Proficiency in molecular biology laboratory techniques required.
Proficiency in basic statistical methods required.
Experience with JMP, MATLAB, or other software tools used for analyzing large datasets preferred.
At least 3 years of laboratory experience in IVD assay development, or at least 6 years of laboratory experience in the field of molecular biology required.
Knowledge and hands-on experience in microbiology preferred.
Willingness to work in a BSL2 laboratory.
Ability to write scientific and/or technical documents, such as experiment plans, protocols and reports.
Ability to properly operate and maintain laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, real-time PCR instruments, biosafety cabinet, refrigerators and freezers.
General computer experience, e.g. Microsoft Office suite, and ability to use corporate data/document/project systems and operate/monitor test equipment.
Effective verbal and written communication with team members, scientists, engineers, and project managers.
Physical Requirements:
Repetitive Motion: liquid transferring pipetter and computer use.
Use of PPE required in laboratory/manufacturing/warehouse areas.
Weight Lifting:
Position: Mostly sitting.
#J-18808-Ljbffr