Full-Time

Design Transfer Scientist

Posted on 11/20/2024

Natera

Natera

1,001-5,000 employees

Genetic testing and diagnostics solutions provider

Biotechnology
Healthcare

Compensation Overview

$108k - $135kAnnually

Mid, Senior

San Carlos, CA, USA

Category
Genomics
Biology Lab & Research
Biology & Biotech
Required Skills
Minitab
Requirements
  • Bachelor's degree with at least 8 years of experience OR Master's degree with 6 years of experience OR PhD with 3 years of experience.
  • Strong scientific background in molecular and cell biology, Biotechnology, or Biochemistry.
  • Experience working to policies; procedures and international quality standards or in a highly regulated industry.
  • Knowledge of quality and regulatory standards and requirements (ISO, CLSI, FDA).
  • Ability to follow and establish SOPs and in-depth knowledge of GLP/GMP guidelines.
  • Experience authoring study plans, protocols and study reports is highly desired.
  • Knowledge of design control.
  • Adept with Excel and basic statistical analysis.
  • Hands-on experience with statistical tools such as Minitab or JMP.
  • Experience with scale up and automation projects is a plus.
  • Experience with molecular biology techniques such as PCR, qPCR and multiplex PCR is a must.
  • Hands-on experience with NGS and DNA/RNA molecular biology is highly preferred.
  • Prior Manufacturing and QC experience is a plus.
  • IVD product development experience is a plus.
  • Very strong analytical and problem-solving skills.
  • Strong interpersonal and communication skills.
  • Effective time management and organizational skills; able to balance multiple priorities.
  • Excellent communication and analytical skills.
  • Proven ability to execute and deliver on commitments.
Responsibilities
  • Assist in test method development and characterization.
  • Participate in specification generation.
  • Plan and execute stability studies.
  • Assist in test method validations and process validations.
  • Collaborate cross functionally to establish supply chain for raw materials and consumables and propose improvements.
  • Participate in collaborative efforts with R&D and subject matter experts for successful transfer of new product designs, including product requirements and material specification development.
  • Serve as lead on automation projects from a design transfer perspective.
  • Perform and document change control activities.
  • Write standard operating procedures (SOPs), study protocols, reports and other documentation.
  • Day-to-day hands on work in the laboratory including generating, recording, and analyzing experimental data.
  • Present status update, data and proposals in various forums to technical and non-technical audiences.
  • Other duties as assigned.

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 and health outcomes through accurate genetic testing.

Company Stage

IPO

Total Funding

$149.9M

Headquarters

Austin, Texas

Founded

2004

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

10%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.
  • AI integration enhances accuracy and speed of Natera's cfDNA analysis.
  • Growing personalized medicine trend aligns with Natera's customized genetic tests.

What critics are saying

  • Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.
  • New Prospera Heart features may face slow adoption by healthcare providers.
  • Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

What makes Natera unique

  • Natera's Signatera test offers personalized ctDNA analysis for cancer patients.
  • Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.
  • Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

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Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

INACTIVE