Senior Manager, NGS Design Transfer & Development

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

Vantaggi offerti da questo lavoro

Health benefits

Fertility benefits

401k benefits

Commuter benefits

Descrizione del lavoro

Natera, a global leader in cfDNA testing, seeks a Senior Manager to lead design transfer from R&D to Operations in Austin, TX. You will manage studies, define transfer plans, and ensure regulatory compliance while mentoring a multidisciplinary team of scientists.

You will partner with QA, Regulatory, and Manufacturing to ensure robust processes, risk management, and timely product launches, delivering high-quality diagnostics.

Competenze

• PhD in molecular biology preferred; Master's or Bachelor's with equivalent experience considered.
• 6–8 years post-PhD biotech experience or >10 years post BS/MS biotech experience.
• At least 4 years managing a team of scientists and research associates.

Mansioni

• Plan and manage late-stage development through launch activities.
• Develop design transfer plans and coordinate with QA/Regulatory partners.
• Lead risk management activities and study designs with statistics groups.
• Guide cross-functional teams to ensure timely product launches.
• Oversee SOPs, verification/validation protocols, and regulatory submissions.
• Mentor scientists, monitor performance, and drive career development.
• Collaborate with Operations, R&D, and Regulatory Affairs for seamless transfer.

Conoscenze

NGS experience

Design transfer

Assay development

Design control

Analytical validation

Manufacturing workflows

SOPs & GLP/GMP

Project management

Statistical analysis

Leadership & mentorship

Formazione

PhD in molecular biology (preferred)

Descrizione del lavoro

Natera, a global leader in cfDNA testing, seeks a Senior Manager to lead design transfer from R&D to Operations in Austin, TX. You will manage studies, define transfer plans, and ensure regulatory compliance while mentoring a multidisciplinary team of scientists.

You will partner with QA, Regulatory, and Manufacturing to ensure robust processes, risk management, and timely product launches, delivering high-quality diagnostics.