Labcorp's Companion Diagnostics (CDx) development lab in Morrisville, NC is seeking a Staff Scientist II/Manager 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 strong analytical skills, and be a self-motivated team player. This is an on-site role.

You will lead critical studies that support CDx development and validation. Experience developing and validating immunoassays is highly desirable (e.g., MSD-ECL, bioMérieux VIDAS, ELISA). 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, developing associate scientists, and contributing to scientific growth of the Labcorp CDx team.

At Labcorp you will...

• Lead assay development projects including direct client facing activities.
• Be responsible for revenue generation by client deliverables.
• Interact directly with pharma clients and regulatory authorities, including FDA.
• Plan and execute experimental designs for using molecular methodologies (immunoassay, qPCR, sequencing, etc.)
• Manage several scientists and research associates.
• Participate in business development activities and presentations to win new business.
• Support the Quality Management System. 

Your background includes...

• PhD in relevant fields (molecular biology, biochemistry, immunology) with 6-8+ years post-degree experience strongly preferred.
• Experience in IVD product development experience, design control, and risk management  
• Experience writing protocols and reports according to recognized standards, inculding CLSI and ISO
• Client-facing industry experience, including strong verbal and written communication skills.
• Experience with statistical programming and software (e.g., R, JMP) is a plus.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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About Labcorp

Clear and confident health care decisions begin with questions. At Labcorp, we’re constantly in pursuit of answers. With unparalleled diagnostics and drug development capabilities, we accelerate innovation and provide insight to improve health and improve lives. Whether you’re a patient, provider, researcher or in the pharmaceutical industry, we’re here for you. More than 70,000 employees strong, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $14 billion in FY 2020.

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