Responsible for hands-on development of ELISA-based diagnostic immunoassays as well as supporting the company's existing ELISA test kit product line. The position will also be responsible for the purification of autoantigens.
- Master's or PhD degree in chemistry, biochemistry, bioengineering, or a related field
- 5+ years of experience in immunoassay development
- Demonstrated track record of solving challenging issues with assay design and development
- Excellent organizational and project management capabilities to facilitate internal and external scientific interactions
- Experience managing direct reports
- Excellent verbal and written communication skills for generating high-quality proposals, presentations, and reports
- Effective at communicating issues, proposing and implementing solutions
- Ability to manage multiple projects and rapidly learn new techniques and approaches
- Ability to work effectively in a cross-disciplinary environment.
- Strong Microsoft Office skills (Excel, Word, PowerPoint)
- Demonstrated track record of bringing ELISA test kits from feasibility through transfer to manufacturing
- Direct, hands-on experience generating analytical assay development, optimization, and validation data packages in accordance with regulatory requirements
- Previous experience with ELISA, antibody conjugation, protein purification
- Experience with cGMP compliant quality systems and the 510(k) approval process
- Drafting and release of standard operating procedures and batch production records
- Experience with HPLC and column chromatography is a must
- Highly motivated and innovative problem solver able to independently design, execute, troubleshoot, and interpret experiments within a co-operative matrixed team environment
Company DescriptionTheraTest provides diagnostic products to clinicians and laboratory professionals worldwide. Our team is dedicated to improving patient outcomes by delivering innovative diagnostic solutions.