POSITION SUMMARY:

The Associate Scientist, IVD Product Development will lead, initiate, execute, analyze, and document product development activities, and verification and validation (V&V) studies, under design control, for next generation sequencing (NGS) assays. Contributes to technical reports to support regulatory submissions. The successful candidate will work closely within the research and development team as well as collaborate cross-functionally with members of biodevelopment, scientific operations, bioinformatics, quality, regulatory affairs and clinical affairs. The candidate will maintain a broad knowledge of state-of-the-art principles and theories. The ideal candidate will be an enthusiastic, flexible team member who learns quickly, enjoys multi-tasking and most importantly, has an interest in our company and our products.

PRIMARY RESPONSIBILITIES:

• Execute development and V&V experiments and analyze data for NGS applications in oncology diagnostics utilizing Natera’s quality system under design control.
• With minimal direction from Manager, plan and execute moderate to high complexity experiments.
• Coordinates the execution and analysis of  studies with biostatistics and bioinformatics teams.
• Contribute to study protocols and technical reports to support FDA submissions.
• Appropriately documents experimental procedures and results according to established guidelines (ISO/CLSI/etc).
• Ensure that the product meets design requirements, such as design input and output, V&V, etc.
• Supervise junior scientists and team members in their experimental execution and technical documentation.
• Participates in project planning and updates. 
• Assist in executing project plans; participates in defining project goals; develops timelines; and contributes to resource requirements.
• Performs data analysis (e.g. R, JMP, Excel).
• Support risk management activities (such as hazard analysis, FMEA). 
• Communicates progress directly with colleagues and senior management.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Employee must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• B.S. with a minimum of 6 years of industry experience, M.S with a minimum of 2 years of industry experience, or Ph.D. with a minimum of 0-2 years of industry experience. 

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must have hands-on experience with NGS and DNA/RNA molecular biology - experience with Illumina required, other technologies (e.g. PacBio, Oxford Nanopore, Ion Torrent, etc.) a plus.
• Must have experience with nucleic acid technologies relating to PCR, qPCR, multiplex PCR, digital PCR, NGS, Epigenetic/methylation, target enrichment.
• IVD product development experience with knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA) is desired. 
• Experience working under design control, authoring study plans, protocols and study reports is highly desired. 
• Strong scientific background in molecular and cell biology, experienced in cell-based technologies and bio-analytical assay development.
• Familiarity with methylation-based technologies and their IVD applications is a plus. 
• Knowledge of assay development and/or product development in an industry setting is desired.
• Demonstrated experience coordinating interdepartmental efforts, generating research hypotheses, analyzing complex problems and data, and bringing products to market.
• Strong interpersonal and communication skills.
• Skilled at writing clear protocols, reports, and SOPs.
• Track record of contributions towards originating, developing and productizing novel nucleic acid techniques and tests.
• Strong research and product development skills with a history of innovation.
• Experience developing tests in oncology or liquid biopsy is a plus.
• Knowledge of statistical methods and techniques to contribute to analytical studies is desired. 
• Ability to follow and establish SOPs and general knowledge of GLP/GMP guidelines.
• Proven success in collaborative and individual projects.
• Ability to work in a fast-paced collaborative team environment.
• Demonstrated success in applying independent scientific judgment in experimental design and analysis.
• Very strong analytical and problem-solving skills.
• Adept with Excel and basic statistical analysis.