Senior Design Transfer Scientist - NGS & IVD Development

Natera; San Carlos (CA); Presencial; USD 137 000 - 171 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Equity awards

Health benefits

401(k) plan

Paid time off

Resumo da oferta

Natera in California seeks a Senior Design Transfer Scientist to lead the transfer of IVD NGS assays from R&D to Operations, balancing hands-on lab work with data analysis and meticulous documentation in a fast-paced, regulated setting.

You will drive design transfer validation, TMV, DHF/DMR maintenance, change control and CAPA investigations, while collaborating cross-functionally to ensure supply chain readiness and on-market support.

Qualificações

• PhD with 4+ years of industry experience OR
• Master's with 7+ years experience OR
• Bachelor's with 10+ years experience in relevant field.

Responsabilidades

• Plan and execute process validations (IQ/OQ/PQ) and stability studies.
• Support TMV development and generation of manufacturing specs.
• Lead Risk Management activities and maintain DHF/DMR.
• Lead change control and assess impact of design changes.
• Investigate deviations, perform root cause analysis, implement CAPA.
• Collaborate cross-functionally to establish material pipelines and present updates.

Conhecimentos

Molecular Biology Experience

Experimental & Analytical Skills

Communication

Execution

Regulatory Knowledge

Study Plans & Reports

Statistics (JMP)

IVD/Medical Device Experience

Manufacturing/Scale-Up

Automated Liquid Handling

Formação académica

PhD in Molecular Biology/related field

Master's in related field

Bachelor's in related field

Ferramentas

JMP

Hamilton

Tecan

Descrição da oferta de emprego

Natera in California seeks a Senior Design Transfer Scientist to lead the transfer of IVD NGS assays from R&D to Operations, balancing hands-on lab work with data analysis and meticulous documentation in a fast-paced, regulated setting.

You will drive design transfer validation, TMV, DHF/DMR maintenance, change control and CAPA investigations, while collaborating cross-functionally to ensure supply chain readiness and on-market support.