Senior Scientist (Lead)- IVD/CDx Assay Development
Residing in our Boulder, CO office, ArcherDX has several openings for a Senior Scientist (Lead)- IVD/CDx Assay Development. As a key member of a rapidly growing Companion Diagnostics team, will lead a group responsible for developing and optimizing IVD assay using cutting-edge NGS technology. Will be responsible for developing, execution, and critical evaluation of experimental designs in support of clinically geared projects leading to the FDA submission.
Will work closely with R&D, Quality, Regulatory, Clinical, and Production teams to translate laboratory processes from feasibility to validated assay. Additionally, will work closely with the Marketing, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong multi-discipline skills from technical, to writing, to communication.
- Participate in the overall product development planning and implementation strategy for Companion Diagnostics and IVD product(s)
- Develop verification and validation protocols under Design Control
- Ensure that all reagents and supplies meet quality control standards
- Lead and support the execution of verification and validation studies
- Analyze study data and write study reports
- Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)
- May serve as a liaison to Clinical Development & Operations for clinical biomarker validation activities
- Participate in drafting technical regulatory documents for CDx and IVD applications for regulatory approval
- Develop status reports for IVD Assay Development management
- Publish scientific results