Are you tired of working at a job where your work feels unimportant? We were too! ArcherDx is a company on the forefront of battling cancer and other genetic diseases utilizing the latest gene sequencing techniques and best-in-class custom software tools. We are pioneering new approaches leveraging molecular diagnostics for the benefit of humanity. As part of a smaller company, your ideas and contributions will have a significant impact on the products ArcherDx supports. These products and services can make a real difference in the quality of diagnosis and long-term welfare of real people.
We’re currently seeking qualified candidates for a Senior Scientist, IVD Product Development role in Boulder, CO. The successful candidate will join a rapidly growing Companion Diagnostics team to lead a group responsible for developing and optimizing one or more IVD assays using cutting-edge NGS technology.
- Drive the overall product development planning and implementation strategy for Companion Diagnostics 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)
- Serve as a liaison to Clinical Development & Operations for clinical biomarker validation activities
- Draft technical regulatory documents for CDx applications
- Develop status reports for Executive Team and external collaborators
- Publish scientific results
- Other duties as assigned
EXPERIENCE AND QUALIFICATIONS
The successful candidate will have an advanced degree in molecular biology, biochemistry, bioengineering or related field, and experience with design control, verification and validation of FDA-regulated products. Other experience and qualifications:
- Proficiency in 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
- Experience with NGS technology is preferred.
- Driven, self-starter who is comfortable in a fast-paced start-up environment
- Effective leadership and communication skills
- Able to organize and prioritize diverse responsiblities to achieve company goals
- High attention to detail, with the ability to create clear and concise technical docoumentation.
- Ability to work in a laboratory environment
- MS/PhD in biology, molecular biology, biochemistry or related field