Staff Scientist, Molecular Biology

Labcorp’s Companion Diagnostics (CDx) development lab in Morrisville, NC is seeking a proactive and motivated Staff Scientist to lead the development of molecular diagnostics for oncology and rare disease indications. The ideal candidate should have experience developing assays in a regulated environment, possess critical thinking skills, and be a self-motivated team player. Experience developing and validating immunoassays is highly desirable (e.g., MSD-ECL, bioMérieux VIDAS).
You will lead critical studies that support CDx development, validation, and deployment into clinical trials. You will support regulatory submissions by providing technical expertise in the planning, execution, and analysis of experiments. You will also support research programs, including new technology development. Your success will be measured by meeting project goals on-time, meeting client expectations, and contributing to scientific growth of the Labcorp CDx team.
At Labcorp you will…
-Lead development projects including direct client facing activities.
-Be responsible for revenue generation by client deliverables.
-Initiate and execute assay adoption at Labcorp clinical testing sites.
-Be a Subject Matter Expert in scientific disciplines.
-Independently plan and execute experimental designs for using molecular methodologies (qPCR, immunoassay, sequencing, etc.)
-Develop technical documents (SOPs, Design Inputs and Outputs, white papers).
-Manage teams in matrix environment.
Participate in business development activities to win new business.
-Support the Quality Management System.

Your background includes…
-PhD in relevant fields (molecular biology, biochemistry, immunology)
-6–8 or more years experience post PhD
-IVD product development experience, design control, and risk management highly desired, knowledge of regulatory requirements, experience authoring study protocols and reports according to recognized standards (CLSI, ISO)
-Experience with statistical programming and software (e.g., R, JMP) is a plus.
-Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast paced and dynamic environment.