Durham, NC 27709
Salary: $66,000.00 to $76,000.00 /year
Scientist III, Assay Development
Baebies, Inc. is an early stage in-vitro diagnostic company addressing unmet needs in infant healthcare. Baebies has developed two in-vitro diagnostic test platforms – Seeker and Finder – based on the digital microfluidics technology. The SEEKER is a high throughput test platform for newborn screening and the FINDER is a sample-to-answer test platform for near-patient use.
We are seeking an Assay Development Scientist to join the Product Development team at Baebies. The Scientist will provide assay development expertise to add new assays to the growing portfolio of test solutions offered on the Baebies product platforms. The Scientist will design and perform studies focused on the development and optimization of new molecular diagnostic assays, clinical chemistry assays and immunoassays.
Roles and Responsibilities
- Develop new molecular diagnostic assays (PCR/RT-PCR), clinical chemistry assays (enzyme, substrate and general chemistry) and immunoassays on the digital microfluidic platform.
- Optimize assay design and reagent formulations using DOE tools to achieve desired levels of performance and stability
- Characterize assay performance across various analytical performance metrics including precision, specificity and sensitivity.
- Derive solutions for technical challenges imposed by system constraints
- Establish product specifications and critical characteristics
- Interface with internal Operations team for design transfer activities
- Analyze experimental results and provide written protocols, reports and oral presentations.
Qualifications and Requirements
- BS with 4+ years of relevant industry experience or MS/PhD with 2+ years of relevant industry experience.
- Experience in in-vitro diagnostic industry is preferred.
- Strong understanding of fundamentals and applications of molecular biology, enzymology and immunology.
- Familiarity with CLSI guidelines, cGMP, FDA requirements preferred.
- Experience with tools such as FMEA, DOE, and root cause analysis.
- Ability to work in a BSL2 lab environment.