Scientist I/II - IVD/CDx Assay Development
Scientist I/II - 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 our Scientist I/II - IVD/CDx assay development. This role is responsible for development, execution, and critical evaluation of experimental designs in support of clinically geared projects. Will routinely generate data in support of Analytical Validation Studies for submission to the FDA.
As familiarity with AMP-based NGS increases, novel approaches to experimental design will be expected. In addition, they will work closely with R&D, Quality, Regulatory, Clinical, and Production teams to translate laboratory processes from feasibility to validated assay. Will work closely with the Marketing, Clinical, and Quality Teams on document drafting, revising, and approval. This position is a key part of the greater IVD Assay Development team, requiring strong multi-discipline skills from technical, to writing, to communication.
RESPONSIBILITIES:
- Technical Content Authorship
- Conduct experiments in support of clinical investigation
- Complete reports and other supporting documentation summarizing experiments
- Design experiments geared toward efficient validation of Archer Assays
- Communicate findings to a non-technical audience
- Work with R&D and QC on document creation/revision
- Routinely generate and edit written technical content
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
REQUIREMENTS:
- BS/MS/PhD in biology, molecular biology, biochemistry or related field and/or equivalent combination of education and experience
- 5+ years of laboratory experience
- 3+ years in an industry setting (preferred)
- Familiarity with NGS (preferred)
- Familiarity with the FDA’s CDx approval process (preferred)
- Must have demonstrated expertise in authoring and presenting scientific molecular biology material.
- Self Starter, driven to perform
- Able to organize and prioritize a diverse set of responsibilities to ensure that focus on success of the company is achieved
- Strong writing and communication
- Strong science acumen