Principal Scientist/ IVD Manager - IVD/CDx Assay Development (ADX-156-19) at ArcherDX
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.
- 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
- MS/PhD in biology, molecular biology, biochemistry or related field
- Minimum 8-10 years' experience in the diagnostic or pharmaceutical industry
- 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
- Effective leadership and communication skills
- 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