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Natera

Director, Research and Product Development (IVD)

3+ months agoSan Carlos, CA

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.

POSITION SUMMARY:

The Director leads IVD product development activities under a design control methodology. Build and manages a team of five direct reports (to start) to ensure product performance by employing proven development practices following IVD recommended guidelines and design approaches. Provides leadership in providing optimal strategy for product design, verification, validation, and technical transfer to CLIA lab and/or external partners. Actively collaborates with Natera's technical, clinical, regulatory and quality assurance team and provides technical expertise and to support corresponding IVD submissions to regulating organizations.



PRIMARY RESPONSIBILITIES:
  • Technical lead on IVD product development activities under a design control. Responsible for providing technical expertise and leadership in product design and development planning, experimental design, experimental execution, data analysis, specification verification, analytical validation and intended use clinical validation.
  • Ensure product performance by employing proven development practices - dFMEA, DOE, guardband testing, gauge R&R, stability/robustness testing, assessment of analytical performance, etc, following CLSI based design.
  • Make fundamental scientific contributions toward producing robust products Develop and implement quality control procedures for critical reagents and processes Perform data analysis with advanced analytical and statistical tools.
  • Communicates results with colleagues and R&D management.
  • Supervises the activities of direct reports or team members at the junior level and manages the execution of large-scale development studies.
QUALIFICATIONS:
  • Ph.D. in molecular biology or related field
  • 10+ years of post Ph.D. biotech industry experience
  • Prior experience in NGS-based IVD product development required
  • Prior experience managing a team
  • Prior experience in development of molecular-based assay for organ health monitoring is a big plus
KNOWLEDGE, SKILLS, AND ABILITIES:
  • Track record of developing diagnostic tests or reagent kits in a regulated environment; knowledge of design control systems, experience assembling IVD documentation
  • Mastery of qPCR/multiplex PCR/hybrid capture - primer design, master mix formulation, protocol optimization; fundamental expertise in nucleic acid quantitation and fragment analysis
  • Hands-on experience with Next Generation Sequencing on Illumina platforms
  • Very strong analytical and problem-solving skills; organized and efficient
  • Proven interpersonal, communication, and presentation skills; excellent time management skills
  • Superb attention to detail; produces work of exceptional quality and accuracy
  • Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities
  • Ability to proactively identify issues and address with a solutions-oriented approach
PHYSICAL DEMANDS & WORK ENVIRONMENT:

Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

  • This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer is required. May stand for extended periods when facilitating meetings.
  • The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
Travel required for this position:
No or Yes _X: If yes state anticipated percent for travel: may be required up to 25%

OUR OPPORTUNITY

Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.

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 OFFER

Competitive Benefits. Generous Employee Referral program. Healthy catered lunches everyday, and premium snacks! Additionally, we offer complimentary premium coffee drinks and teas, and other beverages.

For more information, visit www.natera.com.

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.

Client-provided location(s): San Carlos, CA, USA
Job ID: Natera-7019
Employment Type: Other