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ArcherDX: Senior Scientist – Ruo Assay Development

ArcherDX

This is a Full-time position in Boulder, CO posted September 20, 2020.

Position: Location: Boulder, COJob Id: 863 # of Openings: 1 Senior Scientist RUO Assay Development (ADX-237-20)p.P1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px ‘Helvetica Neue’}p.P2 {margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px ‘Helvetica Neue’; min-height: 14.0px}THE COMPANY:ArcherDX, Inc.

www.ArcherDX.ComArcherDX 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 an opening for aSenior Scientist RUO Assay Development.As a key member of the RUO Assay Development team, the Senior Scientist will be responsible for developing and optimizing assays using cutting-edge NGS technology and applying these assays to customer projects.

Will be responsible for development, execution, and critical evaluation of experiments to optimize assay performance.Will work closely with the Marketing, Clinical, Production, Procurement and Quality Teams on project planning, documentation, data presentation to customers.

Will work closely with in vitro diagnostic and Regulatory teams to translate knowledge from RUO projects into validated assays.

Additionally, the successful candidate will have strong multi-discipline skills from technical, to writing, to communication.RESPONSIBILITIES:Coordination of Personal Cancer Monitoring projects and collaborations.Collaborate with the In vitro diagnostics team to translate results from R& D projects into knowledge usable in the development of IVD assaysParticipate in the overall product development planning and implementation strategyCoordinate across teams to provide customers with data and status reports.Ensure that all reagents and supplies meet quality control standardsAnalyze study data and write study reportsParticipate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)Participate in drafting technical regulatory documents for CDx and IVD applications for regulatory approvalDevelop status reports for Assay Development managementEXPERIENCE:Minimum of 6 years’ experience in the diagnostic or pharmaceutical industryExperience managing teamsExperience communicating with customersFamiliarity with design control, verification and validation of FDA-regulated products.Proficiency in Next Generation Sequencing, PCR, qPCR, and sample prep techniquesStrong data analysis skillsKnowledge of biological and chemical safetyKnowledge of principles of quality control and quality assuranceExcellent writing, communication and organizational skillsAbility to work in a fast-paced environmentSelf-directed: needs little explicit directionAble to organize, prioritize, and delegate tasks to efficiently move projects forward.Effective leadership and communication skillsAble to organize and prioritize diverse responsibilities to achieve company goalsHigh attention to detail, with the ability to create clear and concise technical documentation.Ability to work in a laboratory environmentEDUCATION:MS/PhD in biology, molecular biology, biochemistry or related field