Job Description

Job Description

Job Description

Salary:

Position Title: Staff Scientist Assay Development, Quality, and Manufacturing Support
Department: R&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 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 Masters 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
  Bachelors 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.

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