Energy Jobline ZR
Staff Scientist Assay Development, Quality, and Manufacturing Support in Baltimo
Energy Jobline ZR, Baltimore, Maryland, United States, 21276
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.
QC Method Documentation
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.
Continuous Improvement
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. 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. If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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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.
QC Method Documentation
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.
Continuous Improvement
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. 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. If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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