Title: Research Associate
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, and diagnostic technologies. OPKO Diagnostics is based in Woburn, MA, where we are developing assays for a 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 Research Associate with interest and experience in commercial product development for IVD immunoassays. The candidate will contribute to assay development activities on OPKO’s proprietary microfluidic cassette/platform.
Duties and Responsibilities:
- Design, plan, perform, and document product development activities, including immunoreagent development, immunoassay optimization, and analytical/clinical studies
- Troubleshoot experiments, consult literature and actively propose/pursue solutions
- Characterize biological reagents, write and validate SOP, train and tech-transfer to QC and manufacturing teams
- Assist in the design and development of assays on the Claros platform, contribute to regulatory activities with development reports, and participate in verification / validation activities.
- Work closely with supervisor to meet project deliverables in a timely manner
- Operation of commercial IVD instrument and perform classic ELISA assays
- Strong, independent hands-on experience with molecular biology and/or biochemistry laboratory tasks is required; familiarity with immunoassays is a plus
- Strong Biosafety Level 2 laboratory experience required; must be willing to handle human whole-blood, plasma and/or serum samples
- Capable of organizing and manipulating complex datasets using Microsoft Excel
- Must be self-motivated and able to work in a fast-paced environment
- Excellent organizational skills along with strong written and oral communication skills required
- BS/MS in biology, biochemistry, bioengineering, chemistry, or other Biotechnology-related field required
- Minimum of 2 years of part-time or 1 year of full-time laboratory experience are required.
We offer competitive compensation and an excellent benefit package that includes:
401(k) Plan with Company Match
Paid Time Off
Excellent Medical and Dental Plans
Paid Life Insurance and Disability Insurance
Ability to work in the US without sponsorship is required.