OPKO Diagnostics LLC is a division of OPKO Health, Inc., a publicly traded healthcare company involved in the discovery, development, and commercialization of proprietary pharmaceutical products, medical devices, vaccines, and diagnostic technologies. OPKO Diagnostics is based in Woburn, Massachusetts, where we are developing assays for Point-of-Care diagnostic test system for use in physician offices (Claros), and proprietary diagnostics tests for CLIA-certified laboratories (4KScore).
We are looking for a scientes with strong skills in industrial product development for IVD immunoassays. The candidate will oversee assay development activities, and assist in transfer to manufacturing, regulatory activities and clinical studies. The candidate will report to the Vice President, Assay Development.
DUTIES AND RESPONSIBILITIES:
- Lead immunossay development and standardization activities. Oversee from feasibility through analytical and other pre-clinical studies to support regulatory submissions.
- Assign, direct and evaluate the work of laboratory/research personnel; also oversee the development and maintenance of staff competence.
- Execute development activities to insure robustness of the assay
- Select/prepare biological reagents, develop QC SOPs, and manage the supply chain of critical reagents.
- Assist or lead in the generation of Quality System documentation and approval activities (including: Design Input/Output, Specifications, FMEA, and Design History Files), participate in design review meetings as a key contributor, and assist in the submissions and review of responses to notified bodies and federal agencies relative to medical device directive compliance
- Interface regularly with manufacturing team, QC and QA to facilitate transfer of assay to manufacturing, contribute to generation and approval of technical documentation.
- Ph.D. (or M.S.) in the fields of biochemistry, clinical chemistry, bioengineering or chemistry with experience in leading immunosassy development activities for clincal diagnostics.
- Experience in solid phase modification, reagent formulation and development of assay controls
- Strong background in analytical methodologies, design of experiments (Minitab or JMP) and statistical analysis.
- Motivated team player with attention to detail and ability to prioritize work in a fast paced environment
- Familiarity with CE and FDA regulatory requirements for IVD products and product development under design control.
- Strong English written and oral communication skills, Experience leading teams, training and mentoring staff
- Ability to work in the US without sponsorship is required.