Senior Scientist I
Brava Diagnostics is looking for a Senior Scientist I, with strong skills in commercial product development for IVD immunoassays. The candidate will lead assay development activities on our novel, multiplex point-of-care platform, and will assist in transfer to manufacturing, regulatory activities, and clinical studies. The candidate will report to the Chief Operating Officer.
DUTIES AND RESPONSIBILITIES
- Lead immunoassay and QC methods development, standardization activities and supply chain management. Oversee activities from feasibility through analytical and other pre-clinical studies to support regulatory submissions. Execute product development activities to ensure robustness of the assay on the Brava Diagnostics platform.
- Assign, direct and evaluate the work of laboratory/research personnel. Oversee the professional development of staff.
- Lead/assist in generation and approvals of Quality System documentation, including Design Input/Output, Specifications, FMEA, and Design History Files. Participate in design review meetings as a key contributor.
- Interface with engineering and production staff to ensure reliable transition to manufacturing. Interface regularly with QC and QA to facilitate generation and approval of technical documentation.
- Assist with drafting regulatory submissions and responses to FDA and to notified bodies relative to Medical Device Directive compliance
- Degree in biochemistry, clinical chemistry, bioengineering or chemistry. Ph.D. preferred.
- 5+ years of industry experience in leading immunoassay development teams/activities for clinical diagnostics, with good track record in bringing assays to market (FDA or CLIA).
- Experience in solid phase modification, reagent formulation and development of assay controls.
- Strong background in analytical methodologies and design of experiments (Minitab or JMP) and statistical analysis).
- Familiarity with CE and FDA regulatory requirements for IVD products and product development under design control.
- Motivated team player with attention to detail and ability to prioritize work in a fast-paced environment.
- Strong English written and oral communication skills, Experience leading teams, training and mentoring staff.
- Candidates must have the ability to work in the U.S. without sponsorship.
Compensation and Benefits
We offer competitive compensation and an excellent benefit package that includes medical/dental insurance, paid time off, and 401(k).
Brava Diagnostics is a dynamic start-up company with a team of business and scientific innovators. Our platform consists of a robust fluorescence reader and disposable test cartridges that deliver multiple results from every sample. Our technology solves the need for rapid, simple and quantitative measurement of very low concentrations from whole blood. This combination is critical in acute care settings, where precision at low concentrations is imperative to drive treatment decisions. No other point-of-care platform can deliver laboratory quality results that meet today’s clinical guidelines. Brava tests will support better patient outcomes with greater efficiencies, giving providers confidence to meet the clinical, operational and financial challenges of a changing healthcare landscape.
To apply, please submit your resume and cover letter to CMulherin@BravaDx.com.