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Senior Scientist - IVD/CDx Assay Development (ADX-193-20)

Company: ArcherDX
Location: Boulder
Posted on: September 13, 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 - IVD/CDx Assay Development (ADX-193-20)

Location: Boulder, CO

Job Id: 804

# of Openings: 1

Senior Scientist (Lead)- IVD/CDx Assay Development (ADX-193-20)

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 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

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

1+ year experience managing an assay development project

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

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

Keywords: ArcherDX, Boulder , Senior Scientist - IVD/CDx Assay Development (ADX-193-20), Other , Boulder, Colorado

Click here to apply!

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