Position Title: Staff Scientist – Assay Development, Quality, and Manufacturing Support
Department: R&D / Quality / ManufacturingReports To: VP of Assay Development and Chief Operating OfficerPosition SummaryThe Scientist will play a key role in supporting the development, validation, and manufacturing of Novel Microdevices’ molecular diagnostic assays and reagents. This cross-functional position bridges R&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
- Assay Development & Verification
- Support R&D in the design, optimization, and verification of new molecular diagnostic assays (e.g., qPCR, nucleic acid extraction, reagent formulation).
- Conduct feasibility, design transfer, and V&V (Verification & Validation) testing to ensure product performance and regulatory compliance.
- Perform analytical testing to assess assay sensitivity, specificity, reproducibility, and robustness.
- Analyze, interpret, and present experimental data to cross-functional teams.
Reagent & Manufacturing Support- Collaborate with Manufacturing to scale reagent formulations, optimize processes, and ensure lot-to-lot consistency.
- Conduct in-process, release, and stability testing on raw materials, intermediates, and finished products.
- Develop and refine SOPs, batch records, and test methods for reagent preparation and product release.
- Support troubleshooting of reagent production issues and contribute to process improvements.
- Execute and document QC methods in compliance with ISO 13485, FDA 21 CFR Part 820, and IVDR standards.
- Support method validation, transfer, and verification in alignment with CLSI and internal quality requirements.
- Participate in investigations of nonconformances, OOS/OOT events, and CAPA development.
- Ensure accurate and complete documentation consistent with design control, traceability, and QMS standards.
Cross-Functional Collaboration- Work closely with QA, R&D, and Operations to support technology transfer and readiness for scale-up.
- Provide technical input for product characterization, design reviews, and risk assessments (ISO 14971).
- Train and mentor laboratory staff on analytical methods, data integrity, and best practices.
Contribute to continuous improvement initiatives to strengthen product performance and operational efficiency.
Minimum Qualifications
- PhD or Master’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;ORBachelor’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.
- Hands-on experience with qPCR and molecular assay techniques, including nucleic acid extraction, amplification, or detection.
- Working knowledge of ISO 13485, FDA 21 CFR Part 820, or similar quality management systems.
- Strong experimental design, troubleshooting, and data analysis skills.
- Excellent documentation, organization, and communication skills with a proven ability to collaborate across R&D, Manufacturing, and QA/QC.
Preferred Qualifications
- Experience in IVD assay development and design transfer from prototype to production.
- Familiarity with reagent formulation, lyophilization, or stability studies.
- Prior involvement in V&V studies, design control documentation, or regulatory submissions.
- Knowledge of statistical tools for data trending and method validation (e.g., JMP, Minitab, or equivalent).
- Exposure to risk management (ISO 14971) and document control systems.
