Senior Scientist - IVD/CDx Assay Development (ADX-72-19) at ArcherDX
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- 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
- MS/PhD in biology, molecular biology, biochemistry or related field
- Minimum of 6 years' experience in the diagnostic or pharmaceutical industry
- Experience with design control, verification and validation of FDA-regulated products.
- Proficiency in NGS, PCR, qPCR, and sample prep techniques
- Knowledge of biological and chemical safety
- Knowledge of principles of quality control and quality assurance
- Excellent writing, communication and organizational skills
- Self-Driven, self-starter who is comfortable in a fast-paced start-up environment
- Effective leadership and communication skills
- Able to organize and prioritize diverse responsibilities to achieve company goals
- High attention to detail, with the ability to create clear and concise technical documentation.
- Ability to work in a laboratory environment