Full-Time

Senior Design Transfer Scientist

Posted on 9/6/2024

Natera

Natera

1,001-5,000 employees

Genetic testing and diagnostics solutions provider

Biotechnology
Healthcare

Compensation Overview

$122.1k - $152.7kAnnually

Senior

Austin, TX, USA + 1 more

More locations: San Carlos, CA, USA

This is a hybrid role requiring in-office presence.

Category
Computational Biology
Genomics
Biology Lab & Research
Biology & Biotech
Required Skills
Minitab
Requirements
  • Master's degree with 7 years of experience OR PhD with 4 years of experience required.
  • 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) is a must.
  • Knowledge of design control.
  • 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.
  • Adept with Excel and statistical analysis.
  • Hands on experience with statistical tools such as Minitab or JMP.
  • Supervise junior scientists and team members in their experimental execution and technical documentation.
  • Hands-on experience with molecular biology techniques is a must.
  • Hands-on experience with NGS and DNA/RNA molecular biology is highly preferred.
  • IVD product development experience is a plus.
  • Experience with scale up and automation projects is a plus.
  • Very strong analytical and problem-solving skills.
  • Strong interpersonal and communication skills.
Responsibilities
  • Conduct risk assessments (FMEA) to identify gaps in the process and come up with a strategy to make it compliant with IVD standards.
  • Design and develop manufacturing, QC and commercial operations processes.
  • Plan and executes laboratory research in relation to manufacturing scale up and improving process capability.
  • Assure experimental quality through sound experimental design; utilizes DOE, Cpk analysis, Gage R&R and assists in the design of experiments for others.
  • Plan and conduct stability studies.
  • Lead cross functional efforts in establishing supply chain for raw materials and consumables and propose improvements.
  • Attend core team meetings, serve as a voice of operations and liaison between R&D and Operations.
  • Lead test method developments and characterizations.
  • Conduct studies to generate specifications.
  • Set process and test method specifications based on statistical analysis.
  • Lead test method validations and process validations.
  • Author SOPs, manufacturing and QC documents etc.
  • Write various protocols and reports.
  • Participate in regulatory submission, audit prep and qualification of suppliers and manufacturing processes.
  • Present status update, data and proposals in various forums to technical and non-technical audiences.
  • May lead more junior members of the team.

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 differentiates itself by offering specialized tests like the Signatera ctDNA test and Panorama NIPT for prenatal screening, along with genetic counseling services. The company's goal is to enhance patient care through accurate testing and personalized guidance.

Company Stage

IPO

Total Funding

$149.9M

Headquarters

Austin, Texas

Founded

2004

Growth & Insights
Headcount

6 month growth

9%

1 year growth

25%

2 year growth

66%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increased demand for liquid biopsy techniques boosts Natera's cfDNA testing solutions.
  • Telehealth expansion aligns with Natera's remote genetic counseling services.
  • Growing personalized medicine trend enhances relevance of Natera's ctDNA tests.

What critics are saying

  • Hindenburg report alleges deceptive sales practices, risking legal challenges and reputational damage.
  • New Prospera Heart features may face slow adoption by healthcare providers.
  • Fetal RhD NIPT demand may decline post-RhIg shortage, impacting revenue.

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.
  • Fetal RhD NIPT test addresses RhIg shortage, offering early fetal RhD status detection.

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Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

INACTIVE