Laboratory Operations Lead — Manufacturing & Compliance

Natera; Austin (TX); On-site; USD 132,000 - 165,000; Full time

Benefits offered by this job

Medical benefits

401k benefits

Fertility care benefits

Paid time off

Job summary

Natera in Austin, TX is seeking an Associate Director, Laboratory Operations to lead manufacturing methods, processes, and operations for new and existing products. The role ensures CLIA/CAP and HIPAA compliance while optimizing the use of materials, equipment, and staff.

You will develop budgets, KPI dashboards, and mentor teams to improve production performance across the lab. Collaboration with senior leadership and cross-functional teams is required to drive company objectives.

Qualifications

• BS/BA degree in STEM-related field; Biological Sciences preferred.
• At least 8 years’ experience and with at least 5 years’ experience overseeing manufacturing or a CRO production team at a leadership level

Responsibilities

• Provide operational and strategic leadership to laboratory products assigned to the individual.
• Participate in budget preparation, monitoring of revenue, expenses, test volume, FTE efficiency, and production performance.
• Ensure compliance with all regulatory and legal parameters.
• Lead and manage high performance teams with accountability for operations, quality, and customer service.
• Draft SOWs and process select research samples through the CLIA lab; oversee method validation and transfer.
• Develop KPIs and analyze opportunities to optimize department performance.
• Direct production laboratory personnel in manufacturing activities including method validation and in-process testing.
• Develop or oversee lab production processes and procedures; authorize implementation.
• Mentor staff through development reviews, coaching, and training.
• Collaborate with direct reports to set professional development goals and foster a positive environment.
• Provide executive level production summaries.
• Represent the company during audits, visits, and client calls.
• Build partnerships with department heads to drive business objectives.
• Set objectives and schedules; delegate as needed.
• Engage with senior management regularly; work with PHI on a regular basis.
• Complete HIPAA/PHI privacy and compliance training within 30 days of hire.
• Maintain current status on Natera training requirements.
• Perform other duties as assigned.

Skills

Leadership

Budgeting

Regulatory compliance

GxP

HIPAA/PHI awareness

Communication

Project management

Team building

Education

BS/BA in STEM

Tools

Microsoft Office Suite

Google Workspace

Job description

Natera in Austin, TX is seeking an Associate Director, Laboratory Operations to lead manufacturing methods, processes, and operations for new and existing products. The role ensures CLIA/CAP and HIPAA compliance while optimizing the use of materials, equipment, and staff.

You will develop budgets, KPI dashboards, and mentor teams to improve production performance across the lab. Collaboration with senior leadership and cross-functional teams is required to drive company objectives.