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Principal Scientist - IVD/CDx Assay Development

Company: ArcherDX
Location: Boulder
Posted on: September 13, 2020

Job Description:

National Postdoctoral Association Career Center Principal Scientist - IVD/CDx Assay Development

Principal Scientist - IVD/CDx Assay Development Principal Scientist - IVD/CDx Assay Development

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.

SUMMARY:

Residing in our Boulder, CO office, ArcherDX has several openings for a Principal Scientist - IVD/CDx Assay Development . Will be a key member of a rapidly growing Diagnostics team. Responsible for developing, executing, and critical evaluation of experimental designs in support of clinically oriented products intended for regulatory submission.

Will work closely with R&D, Quality, Regulatory, Clinical Development, Production teams and external pharma partner to translate laboratory processes from feasibility to validated assay. Additionally, will work closely with the Marketing, Medical, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong leadership and multi-disciplinary skills including expertise in biochemistry/molecular biology, technology, analytical validation including study design and interpretation of data, and excellent written and oral communication.

Manage and oversee a technical team in full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources

Oversee overall product development planning and implementation strategy for Diagnostic product(s)

Develop verification and validation protocols under Design Control

Manage and oversee a technical team in execution of verification and validation studies

Oversee the study data analysis and study report writing

Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)

Participate in the planning, writing and implementation of laboratory focused clinical trials and collaborative studies.

Serve as a liaison to Technical, Clinical Development and Operations for clinical biomarker validation activities

Draft technical regulatory documents for regulatory applications

Develop status reports for Executive Team and external collaborators

Publish scientific results

Requirements

QUALIFICATIONS:

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

Minimum 8-10 years' experience in the diagnostic or pharmaceutical industry

1+ year experience managing an assay development project

1+ year managing direct report

Experience developing NGS assays

Knowledge of principles of quality control and quality assurance

Design control, verification and validation of FDA-regulated products

Proficiency in NGS, PCR, qPCR, and sample prep techniques

Experience writing protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications

Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management

Strong regulatory experience with the FDA

Experience growing a team to meet company growth objectives

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

Demonstrates strong leadership capabilities with the ability to lead multiple projects through a complex development program

Handles tight timelines and stress in a constructive manner

High attention to detail, with the ability to create clear and concise technical documentation

Job Information

Job ID: 54352390

Location:

Boulder, Colorado, United States

Position Title: Principal Scientist - IVD/CDx Assay Development

Technology Development Engineer/Scientist 15800 Crabbs Branch Way, Rockville, Maryland 20855 (301) 984-4800

Keywords: ArcherDX, Boulder , Principal Scientist - IVD/CDx Assay Development, Other , Boulder, Colorado

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