Scientist, IVD Product Development

Company: Tbwa Chiat/Day Inc
Location: San Carlos
Posted on: March 31, 2025

Job Description:

The Scientist, IVD Product Development will plan, 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 bio development, scientific operations, bioinformatics, quality, regulatory affairs and clinical affairs. The Scientist is expected to divide time between working in the lab and at the desk and providing guidance and training junior team members in their execution of NGS experiments to support in vitro diagnostic (IVD) development. 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:

• Design and execute development and V&V experiments and analyze data for NGS applications in oncology diagnostics utilizing Natera's quality system under design control.
• Independently lead and manage in-lab efforts to design and execute moderate to high complexity experiments.
• Coordinates the execution and analysis of studies with biostatistics and bioinformatics teams.
• Author associated documentation, 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.
• Employee must pass a post offer criminal background check.QUALIFICATIONS:
  • B.S. with a minimum of 8 years of industry experience, M.S with a minimum of 5 years of industry experience, OR Ph.D. with a minimum of 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.
    • Knowledge of methylation-based technologies and their IVD application is a plus.
    • 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 supervising scientific staff, 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.The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.$108,800 - $135,950 USDOUR OPPORTUNITYNatera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.WHAT WE OFFERCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.If you are based in California, we encourage you to read this important information for California residents.Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
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Keywords: Tbwa Chiat/Day Inc, San Francisco , Scientist, IVD Product Development, Other , San Carlos, California