Senior Scientist - IVD/CDx Assay Development (ADX-72-19)
Senior Scientist (Lead)- IVD/CDx Assay Development
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.
POSITION SUMMARY:
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.
RESPONSIBILITIES:
- 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
QUALIFICATIONS:
- MS/PhD in biology, molecular biology, biochemistry or related field
- Minimum of 6 years' experience in the diagnostic or pharmaceutical industry
- 1+ year experience managing an assay development project
- 1+ year managing direct reports
- Experience developing NGS assays
- 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
- 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