Position Summary

Biomeme is seeking a highly motivated Staff Scientist, Molecular Biology & Assay Development to support the development, optimization, and validation of molecular assay, sample preparation chemistry, and instrument systems. This individual will design, optimize, and validate isothermal molecular diagnostic assays across our point-of need testing platforms, working cross-functionally with engineering, quality, manufacturing, and regulatory teams to bring new assays from concept through to successful commercial launch. The role reports to the Director of R&D and carries significant technical ownership over assay design decisions.

Key Responsibilities
• Design, develop, and optimize isothermal molecular assays (primer/probe design, multiplexing, sensitivity/specificity optimization) for regulated and RUO point-of-need molecular diagnostic applications.
• Lead assay validation and verification studies (analytical sensitivity, specificity, precision, reproducibility, stability) in support of product launches and regulatory submissions.
• Troubleshoot assay performance issues across development, pilot, and manufacturing scale, identifying root causes and implementing corrective actions.
• Collaborate with product management, hardware/software engineering, and manufacturing teams to ensure assay designs are compatible with platform requirements and are manufacturable at scale.
• Author and review technical protocols, study reports, SOPs, and design history file documentation in compliance with quality system requirements (e.g., ISO 13485, FDA QSR as applicable).
• Mentor and provide technical guidance to associate/junior scientists and research associates.
• Stay current with advances in molecular diagnostics, sample preparation chemistry, and point-of-care testing technology, and evaluate new methods or reagents for potential incorporation into the product pipeline.
• Present technical findings to cross-functional stakeholders and, as needed, external partners or customers.

Required Qualifications
• Degree in Molecular Biology, Biochemistry, Microbiology, Genetics, or a related life sciences field, with one of the following experience profiles: BS with 8-10+ years of relevant experience, MS with 3-5 years of relevant experience, or PhD with 0-2 years of relevant experience.
• Hands-on expertise in molecular assay design and development, including primer/probe design and multiplex assay optimization.
• Strong RNA handling and analysis experience.
• The ability to perform hands-on bench work from day one, including sample preparation, quantification, amplification, and assay optimization.
• Demonstrated experience taking assays through analytical validation and into a commercial or clinical product.
• Experience with solid-phase nucleic acid extraction, amplification chemistry, and molecular diagnostic workflows.
• Experience working within a quality system environment (design controls, documentation practices, change control).
• Strong technical documentation skills.
• Ability to present technical data and findings to mixed technical and non-technical audiences.
• Demonstrated history of learning new skills and techniques and applying them to solve problems.
• Excellent time management

Preferred Qualifications
• Experience developing assays for point-of-need or field-deployable molecular diagnostic platforms.
• Experience supporting regulatory submissions, including FDA 510(k)/EUA for IVD products.
• Experience with automated liquid handling, high-throughput screening, or bioinformatics tools for primer/probe design.
• Molecular biology reagent kit development experience, including nucleic acid amplification, .
• Experience with digital PCR.
• Experience with LAMP (loop-mediated isothermal amplification).
• Surface chemistry and/or bioconjugation experience.
• Formulation chemistry experience for
• BSL2 experience.
• Experience with Python, R or similar data analysis code.

Work Environment & Physical Requirements
• Primarily laboratory-based role requiring standard PPE and adherence to laboratory safety protocols.
• Ability to perform bench work including standing, sitting, and repetitive hand motions for extended periods.
• Occasional handling of BSL 1 and BSL 2 biological samples and reagents in accordance with biosafety guidelines.