Sr. Scientist - Immunoassay Development and Validation
At Quest, our R&D professionals play an essential role in our success and in the services we provide. As a career, we offer a unique opportunity to develop your career. The R&D team strives to advance technology necessary to develop state-of-the-art diagnostic tests.
As a member of the Immunology R&D team, the Scientist will work alongside other Scientists and staff from cross-functional teams to develop, validate and commercialize immunoassays testing. This role supports development of laboratory- developed tests and IVD products.
- Serves as a technical leader on individual assignments and on project teams
- Under the direction of the Scientific Director, Lead Scientist or R&D Manager, initiate experimental design for assay development.
- Conduct assay system development, optimization and validation.
- Prepare technical documentation including SOPs, work instructions, specifications, study protocols, and study reports.
- Provide technical guidance to junior level scientific staff
- Coordinate technical transfer of new assays and procedures to appropriate department.
- Assist in the training of lab personnel on new procedures.
- Provide scientific supervision and guidance to junior level staff
- Prepare written and oral presentations of scientific updates for presentation at R&D meetings and conferences.
- Maintain awareness of current and developing technologies.
- Interact with Academic Associates and other outside sources of emerging technologies, science and materials.
- Complies with industry regulatory and quality standards for the R&D Assay Design Control processes.
- Assists with troubleshooting, including reviewing procedural execution for possible cause of unexpected/abnormal results.
- At least 6 years relevant experience in a research and development laboratory for candidates with a BS/BA degree;
- At least 4 years experience for candidates holding an MS/MA degree;
- 2-5 years experience for candidates holding a Ph.D. degree.
- Experience with immunoassays including ELISA and high sensitivity immunoassays, such as MSD.
Preferred Work Experience:
- IVD development experience including all aspects of design control and risk management is a strong advantage
- Previous mammalian cell culture experience and work with cell-based assays
- Experience in a GMP or QSR environment
- Theory and practice of immunoassay development
- Knowledgeable in the use of common laboratory equipment
- Knowledgeable in the safe handling of chemicals and biological samples
- Proven ability to accomplish technical tasks both independently and as a member of a research team.
- Able to work well in a multifunctional team environment
- Excellent written and verbal communication, organizational and interpersonal skills are required.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance and correlation techniques.
- Ability to define problems, collect data, establish facts, and draw valid conclusions
Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.