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Senior Scientist - RUO Assay Development (ADX-237-20)

Company: ArcherDX
Location: Boulder
Posted on: September 17, 2020

Job Description:

At ArcherDX, we’re never done learning with our commitment to growing professionally and personally.

We’re passionate about making a positive impact on human health through our fight against cancer.

We’re armed with cutting-edge technology, but our upper hand comes from the people on our team.

We’re seeking ambitious individuals who share our values of accountability, care, grit, truth and urgency.

2477 55th Street, Suite 202 Boulder, CO 80301

Position: Senior Scientist - RUO Assay Development (ADX-237-20)

Location: Boulder, CO

Job Id: 863

# of Openings: 1

Senior Scientist - RUO Assay Development (ADX-237-20)

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 an opening for a Senior 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 assays

Participate in the overall product development planning and implementation strategy

Coordinate across teams to provide customers with data and status reports.

Ensure that all reagents and supplies meet quality control standards

Analyze study data and write study reports

Participate 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 approval

Develop status reports for Assay Development management

EXPERIENCE:  Minimum of 6 years' experience in the diagnostic or pharmaceutical industry

Experience managing teams

Experience communicating with customers

Familiarity with design control, verification and validation of FDA-regulated products.

Proficiency in Next Generation Sequencing, 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

Ability to work in a fast-paced environment

Self-directed: needs little explicit direction

Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

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

EDUCATION: MS/PhD in biology, molecular biology, biochemistry or related field

Keywords: ArcherDX, Boulder , Senior Scientist - RUO Assay Development (ADX-237-20), Other , Boulder, Colorado

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