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Design Transfer Scientist

4 weeks ago
United States
Full-time
Senior
Operations Specialist
Quality Assurance and Testing
Statistics
Apply Now
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004
View All Jobs 63

Description

  • Own and execute process validations, stability studies, and study protocols, and convert experimental data into final technical reports.
  • Support test method development, characterization, and Test Method Validation (TMV) to define accurate manufacturing specifications.
  • Lead risk management activities, including FMEAs, to identify and mitigate product risks early.
  • Manage change control workflows to assess and document the operational impact of design changes on marketed products.
  • Investigate product and process deviations, perform root cause analysis, and implement corrective and preventive actions (CAPA).
  • Coordinate cross-functionally with automation engineering, laboratory operations, bioinformatics, statistics, project management, and product management to drive project execution.
  • Partner with Supply Chain to establish reliable raw material and consumable pipelines.
  • Communicate technical updates, data-driven proposals, and project status to cross-functional stakeholders.

Requirements

  • BA/BS with 8+ years of experience, MS with 5+ years of experience, or PhD with 3+ years of experience in assay development and automation for the life sciences industry.
  • Experience with automated high-throughput NGS assays.
  • Hands-on expertise with NGS workflows, including DNA/RNA extraction, targeted enrichment, or library preparation.
  • Direct experience with molecular biology techniques such as nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies.
  • Strong knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards such as FDA, ISO 13485, and CLSI in regulated clinical diagnostic manufacturing environments.
  • Proven ability to author study plans, validation protocols, and technical reports.
  • Proficiency in statistical analysis tools such as Minitab or JMP.
  • Prior experience in IVD product development, scale-up, manufacturing, or commercial Quality Control (preferred).
  • Experience operating or optimizing automated liquid handling platforms such as Hamilton or Tecan (preferred).
  • Strong organizational skills to manage complex validation timelines and technical projects.

Benefits

  • Base salary range of $116,160 to $145,200 USD.
  • Annual performance incentive bonus.
  • Long-term equity awards.
  • Comprehensive health benefits, including medical, dental, and vision coverage.
  • 401(k) with company match.
  • Generous paid time off and company holidays.
  • Additional wellness and work-life benefits.
  • Employee benefits including life and disability coverage, fertility care benefits, pregnancy and baby bonding leave, commuter benefits, and employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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