Protein Conjugation Chemist
Brava Diagnostics is looking for a Protein Conjugation Chemist with experience in commercial product development for IVD immunoassays. The candidate will contribute to assay development activities on our novel, multiplex point-of-care platform. The Conjugation Chemist works collaboratively with all departments within the company, and with external suppliers, to optimize the process development and transfer of protein conjugation projects. The individual will apply his/her expertise in protein chemistry, purification, conjugation, and process scale-up to develop protein conjugate processes suitable for cGMP manufacturing. The position will report to the Chief Operating Officer.
DUTIES AND RESPONSIBILITIES
- Develop processes for the conjugation, purification and formulation of antibody/protein conjugates.
- Design, develop and verify manufacturing and testing processes for chemical and biological materials.
- Develop, implement, and maintain the appropriate quality specifications, records and procedures.
- Develop analytical methods to support process development.
- Performs process robustness, optimization and characterization using DOE approaches.
- Process scale up and transfer into cGMP facilities.
- Training other Operations personnel on use of HPLC/UPLC equipment and processing.
- Support in vitro diagnostic regulatory compliance to FDA, ISO, European Union, and other regulatory requirements, such as record keeping, corrective actions, nonconformance control and inspection.
- Ph.D. or M.S. in in a relevant scientific discipline (Chemistry, Chemical Engineering or Biochemistry).
- A high degree of familiarity with development of IVD products and the associated regulatory framework.
- 3+ years experience in protein conjugation and purification.
- Direct experience in conjugation of monoclonal antibodies to small molecules, protein purification, and process scale-up is very desirable.
- Good knowledge of different chromatographic principles and hands-on experience with HPLC methods.
- Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team.
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.