Labcorp's Companion Diagnostics (CDx) development lab in Morrisville, NC is seeking a Staff Scientist II to lead the development of molecular diagnostics across multiple therapeutic indications, including rare diseases and oncology. The ideal candidate should have experience developing NGS and other molecular assays in a regulated environment, possess strong analytical skills, and be a self-motivated team player.
You will lead critical studies that support CDx development and validation. This is an on-site role that include hands-on lab work and some managerial responsibilities. You will support regulatory submissions by providing technical expertise in the planning, execution, and analysis of experiments.
Your success will be measured by meeting project goals on-time and within budget, meeting client expectations, developing associate scientists, and contributing to scientific growth of the Labcorp CDx team.
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Job Description:
- Lead assay development projects including direct client facing activities.
- Manage several research associates and scientists.
- Interact directly with pharma clients and regulatory authorities, including FDA.
- Be responsible for revenue generation by client deliverables.
- Plan and execute experimental designs for using NGS and other molecular methodologies.
- Participate in business development activities and presentations to win new business.
- Support the Quality Management System.
Education and Experience:
- PhD in relevant fields (molecular biology, biochemistry) 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, including 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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