Senior Scientist - RUO Assay Development (ADX-237-20)
Senior Scientist - RUO Assay Development (ADX-237-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
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
- Strong data analysis skills
- 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