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Full-Time

Senior Scientist

R&D

Confirmed live in the last 24 hours

Natera

Natera

1,001-5,000 employees

Biotechnology firm specializing in genetic testing

Biotechnology
Healthcare

Compensation Overview

$106.2k - $132.7kAnnually

Senior

Austin, TX, USA + 2 more

More locations: San Carlos, CA, USA | Remote in USA

Position can work out of San Carlos, CA, Austin, TX, or remote.

Category
Genomics
Biology & Biotech
Requirements
  • PhD degree in Molecular Biology, Biochemistry, or related field with 4+ years industry experience in developing NGS based assays from concept to commercialization. Masters or Bachelors candidates with 6+ years or 8+ years, respectively, may also be considered.
  • Experience with assay workflow development, optimization required.
  • Demonstrated experience with standard processes and approaches for IVD verification and validation required.
  • Experience in IVD development for NGS applications is required.
  • Knowledge of quality and regulatory requirements (ISO 13485, 21 CFR Part 820, Risk Analysis ISO 14971) is highly required.
  • Experience in preparing technical summaries for regulatory submission (including ex-US) is highly desirable.
  • Knowledge of DOE and Statistical methods highly desirable.
  • Solid skills in document writing; development of reports, plans, work instructions, technology transfer from R&D to manufacturing required.
  • Comfortable in a role of technical leader for a project, willingness to direct and manage project activities for team members as well as function as an individual contributor to the team.
  • Willing to analyze results from both the perspective of product development and requirements for robust products and the perspective of the customer.
  • Detail-oriented, organized, ability to plan, design and oversee execution of protocols.
  • Analytical, detail oriented, organized, efficient, problem solver.
  • Must have a desire to be part of a fast-paced and dynamic development environment.
  • Excellent communication skills, both written and verbal.
Responsibilities
  • Contribute to experimental study design and oversee documentation, execution and data analysis of experiments for various development projects for FDA-regulated products (510K, de-novo, CDx).
  • Accountable for preparing technical summaries for submission to regulatory bodies, such as the FDA, PMDA, IVDR, etc.
  • Closely coordinate with matrixed teams on projects throughout design-controlled product development phases, contribute to core teams, and work with cross-functional leads from Product and Program Management to deliver development milestones for best-in-class IVD products.
  • Responsible for owning, creating and maintaining several design control deliverables such as Design Inputs/Outputs, Trace Matrix, FMEAs, development and design verification and validation study plans, stability plans, among others, as applicable.
  • Assist with external-facing discussions and collaborations with Biopharma partners and regulatory bodies.
  • Analysis and presentation of complex datasets with the support of bioinformatic scientists.
  • Contribute to the overall success of projects; anticipate problems to minimize issues and work to resolve any issues to mitigate impact on success of project.
  • Mentor, direct and assist junior scientific staff setting an example for good scientific practices.
  • Write experimental reports, summaries and protocols for supervisors, project needs, and other teams as appropriate.
  • Assist with strategy, risk management, documentation, and improvement of processes, as applicable.

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care through accurate genetic insights and early detection of health issues.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

Austin, Texas

Founded

2004

Growth & Insights
Headcount

6 month growth

11%

1 year growth

21%

2 year growth

61%
Simplify Jobs

Simplify's Take

What believers are saying

  • Natera's continuous innovation, such as the launch of the Prospera Heart test with DQS, demonstrates its commitment to improving patient outcomes and maintaining market leadership.
  • The company's diverse product offerings across oncology, transplant health, and women's health provide multiple revenue streams and reduce dependency on a single market.
  • Significant investments from entities like Massachusetts Financial Services Co. MA indicate strong financial backing and confidence in Natera's growth potential.

What critics are saying

  • Allegations of deceptive sales and billing practices could damage Natera's reputation and lead to legal and financial repercussions.
  • The highly competitive nature of the genetic testing market requires constant innovation and differentiation to maintain market share.

What makes Natera unique

  • Natera's focus on cell-free DNA (cfDNA) technology for a wide range of applications, from oncology to prenatal screening, sets it apart from competitors who may specialize in only one area.
  • The introduction of unique features like the Donor Quantity Score (DQS) for transplant rejection detection enhances the accuracy and reliability of their tests, distinguishing them from other genetic testing companies.
  • Natera's extensive portfolio of over 200 peer-reviewed publications underscores its commitment to scientific validation and credibility, which is a significant competitive advantage.

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Benefits

Flexible medical plans

Investment options

Time off

Workplace perks