Qureos Mentor

Novel Microdevices

<div>Position Title: Staff Scientist &ndash; Assay Development, Quality, and Manufacturing Support 
Department: R&amp;D / Quality / Manufacturing 
Reports To: VP of Assay Development and Chief Operating Officer 
Position Summary

The Scientist will play a key role in supporting the development, validation, and manufacturing of Novel Microdevices&rsquo; molecular diagnostic assays and reagents. This cross-functional position bridges R&amp;D, Quality Control, and Manufacturing, ensuring that new assays and production lots meet performance, consistency, and regulatory requirements.

The ideal candidate is a hands-on scientist who enjoys both bench-level experimentation and structured quality processes, thrives in a fast-paced startup environment, and contributes to the continuous improvement and commercialization of diagnostic products. 

Key Responsibilities
<ul>
<li>Assay Development &amp; Verification
<ul><li>Support R&amp;D in the design, optimization, and verification of new molecular diagnostic assays (e.g., qPCR, nucleic acid extraction, reagent formulation).</li>
<li>Conduct feasibility, design transfer, and V&amp;V (Verification &amp; Validation) testing to ensure product performance and regulatory compliance.</li>
<li>Perform analytical testing to assess assay sensitivity, specificity, reproducibility, and robustness.</li>
<li>Analyze, interpret, and present experimental data to cross-functional teams.</li>
</ul>Reagent &amp; Manufacturing Support
<ul><li>Collaborate with Manufacturing to scale reagent formulations, optimize processes, and ensure lot-to-lot consistency.</li>
<li>Conduct in-process, release, and stability testing on raw materials, intermediates, and finished products.</li>
<li>Develop and refine SOPs, batch records, and test methods for reagent preparation and product release.</li>
<li>Support troubleshooting of reagent production issues and contribute to process improvements.</li></ul> 
 
<ul><li>Execute and document QC methods in compliance with ISO 13485, FDA 21 CFR Part 820, and IVDR standards.</li>
<li>Support method validation, transfer, and verification in alignment with CLSI and internal quality requirements.</li>
<li>Participate in investigations of nonconformances, OOS/OOT events, and CAPA development.</li>
<li>Ensure accurate and complete documentation consistent with design control, traceability, and QMS standards.</li>
</ul>Cross-Functional Collaboration
<ul><li>Work closely with QA, R&amp;D, and Operations to support technology transfer and readiness for scale-up.</li>
<li>Provide technical input for product characterization, design reviews, and risk assessments (ISO 14971).</li>
<li>Train and mentor laboratory staff on analytical methods, data integrity, and best practices.</li>
</ul>Contribute to continuous improvement initiatives to strengthen product performance and operational efficiency.</li></ul> 


Minimum Qualifications
<ul>
<li>PhD or Master&rsquo;s degree in Molecular Biology, Biochemistry, Biotechnology, or a related life science field, or equivalent experience in assay development or molecular diagnostics; with at least 2 years of relevant experience; 
OR 
Bachelor&rsquo;s degree in a related discipline with at least 5 years of relevant experience in assay development, molecular biology, or quality control within a regulated IVD or life sciences environment.</li>
<li>Hands-on experience with qPCR and molecular assay techniques, including nucleic acid extraction, amplification, or detection.</li>
<li>Working knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality management systems.</li>
<li>Strong experimental design, troubleshooting, and data analysis skills.</li>
<li>Excellent documentation, organization, and communication skills with a proven ability to collaborate across R&amp;D, Manufacturing, and QA/QC.</li></ul> 


Preferred Qualifications
<ul>
<li>Experience in IVD assay development and design transfer from prototype to production.</li>
<li>Familiarity with reagent formulation, lyophilization, or stability studies.</li>
<li>Prior involvement in V&amp;V studies, design control documentation, or regulatory submissions.</li>
<li>Knowledge of statistical tools for data trending and method validation (e.g., JMP, Minitab, or equivalent).</li>
<li>Exposure to risk management (ISO 14971) and document control systems.</li></ul></div>

Staff Scientist – Assay Development, Quality, and Manufacturing Support

Join Novel Microdevices and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Novel Microdevices

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Staff Scientist – Assay Development, Quality, and Manufacturing Support