Senior Design Transfer Manager – NGS & QC

Natera, Inc.; Austin (TX); In loco; USD 143.000 - 179.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability plans

Free genetic testing

Fertility care

401k

Commuter benefits

Employee referral program

Descrizione del lavoro

Natera, Inc. in Austin, TX seeks a Senior Manager of Development and Design Transfer to lead the transfer of NGS-based assays from R&D into Operations.

You will plan, execute, document, and validate design transfer activities under Quality Systems Regulations and Design Control, coordinating with cross-functional teams to meet milestones. The role requires mentoring a multidisciplinary science group, building robust processes, and ensuring regulatory compliance.

Competenze

• Advanced degree in molecular biology or related discipline. PhD preferred; Masters or Bachelors with equivalent industry experience considered.
• 6-8 years of post PhD biotech industry experience or >10 years of post BS/MS biotech experience
• At least 4 years managing a team of scientists and research associates

Mansioni

• Plan and manage activities and studies from late-stage development to launch
• Lead design transfer plans and coordinate transfer from R&D to manufacturing
• Lead test method development, characterization, and validation
• Ensure compliance with FDA, ISO 13485 and QSR during design transfer and production
• Communicate progress to senior management and cross-functional teams
• Mentor and develop scientists and ensure group effectiveness

Conoscenze

NGS knowledge

Design transfer

Regulatory compliance

Leadership

DOE analysis

Statistical analysis

Project management

Formazione

PhD in molecular biology

Masters or Bachelors with equivalent experience

Descrizione del lavoro

Natera, Inc. in Austin, TX seeks a Senior Manager of Development and Design Transfer to lead the transfer of NGS-based assays from R&D into Operations.

You will plan, execute, document, and validate design transfer activities under Quality Systems Regulations and Design Control, coordinating with cross-functional teams to meet milestones. The role requires mentoring a multidisciplinary science group, building robust processes, and ensuring regulatory compliance.