Associate Director, Laboratory Operations

About the role

Natera is seeking a leader to manage manufacturing methods, processes, and operational workflows for our laboratory products. You will oversee budget management, regulatory compliance, and staff development while ensuring high-quality production standards. In this capacity, you will be responsible for the end-to-end execution of assigned laboratory product lines, translating strategic objectives into daily operational actions. You will foster a culture of accountability and continuous improvement within the production environment. The role requires a proactive approach to identifying risks and implementing controls to maintain operational integrity. You will act as a key interface between scientific operations and executive leadership. Success in this position will be defined by your ability to deliver consistent, high-quality results in a regulated setting.

Key facts

What you'll do

• Provide strategic and operational leadership for assigned laboratory product lines.
• Monitor production performance, including test volume, report turnaround times, and FTE efficiency.
• Ensure strict adherence to CLIA/CAP guidelines and other regulatory requirements.
• Draft Statements of Work and manage the processing of research samples.
• Define and track departmental KPIs to identify process improvements.
• Lead method validation, method transfer, and in-process testing activities.
• Mentor and coach direct reports to foster professional growth and team engagement.
• Represent the company during audits, client calls, and technical meetings.
• Handle protected health information (PHI) in compliance with HIPAA standards.
• Analyze workflow bottlenecks and implement corrective actions to optimize throughput.
• Develop and maintain standard operating procedures to ensure compliance and consistency.
• Collaborate with cross-functional teams to align laboratory operations with business goals.
• Evaluate and recommend new technologies to enhance production capabilities.
• Oversee inventory management and quality control of laboratory reagents and supplies.

Requirements

• Bachelor's degree in a STEM field, preferably in Biological Sciences.
• Minimum of 8 years of professional experience.
• At least 5 years of leadership experience in manufacturing or a Contract Research Organization (CRO) production environment.
• Ability to complete HIPAA/PHI and security training within 30 days of hire.
• Proficiency in Molecular Biology.
• Demonstrated experience with quality management systems and standard operating procedures.
• Strong understanding of Good Manufacturing Practices (GMP) and Current Good Laboratory Practices (cGLP).
• Capability to manage multiple priorities in a fast-paced, regulated environment.

Nice to have

• Experience managing a CLIA/CAP CRO production team.

Skills & tools

• Microsoft Office Suite (Word, PowerPoint, Excel).
• Google Workspace (Gmail, Calendar, Drive, Chat).
• Strong organizational and communication skills.

Practical notes

• Benefits include comprehensive medical, dental, vision, life, and disability insurance.
• Additional perks include fertility care benefits, pregnancy and baby bonding leave, 401k, and free testing for employees and immediate family.
• Natera only contacts candidates via @natera.com email addresses and does not conduct interviews via text message.
• This position is based in Austin, Texas, and requires physical presence in the office.
• The engagement is full-time, with standard business hours as determined by operational needs.
• Candidates must be eligible to work in the United States without sponsorship for this role.
• All hired individuals must successfully pass background checks and drug screening as required by company policy.
• Travel is not expected for this role unless specifically required for audits or special projects, which will be communicated in advance.
• This role is subject to the terms and conditions of employment outlined in Natera's personnel policies.
• New employees are expected to complete all onboarding documentation and training modules within the specified timeframe.
• Continued employment is contingent upon the maintenance of required certifications and compliance with regulatory standards.
• The successful candidate will be required to sign confidentiality and intellectual property agreements.
• Performance reviews will be conducted annually, with goals and expectations set in collaboration with management.
• This position offers opportunities for professional development through internal training programs and external certifications.
• The department operates under strict regulatory guidelines, and adherence to these policies is mandatory.
• Reporting structures are clearly defined, and direct reports will be expected to provide regular status updates.
• The candidate must demonstrate the ability to work effectively within a matrixed organization.
• This role requires a high level of integrity, discretion, and commitment to operational excellence.
• The successful applicant will be responsible for ensuring that all laboratory activities are documented accurately and retrievably.
• Continuous improvement initiatives are encouraged, and the candidate should be prepared to lead process optimization projects.
• All personnel are expected to participate in company-wide initiatives and cross-departmental collaborations.
• The role requires a deep understanding of the complexities of clinical laboratory operations.
• The candidate must be comfortable working with sensitive data and confidential information on a daily basis.
• Proficiency in data analysis and reporting tools is essential for tracking departmental performance.
• The ability to lead and manage remote or hybrid team members is a distinct advantage.
• This position plays a critical role in supporting the company's mission of improving health outcomes through innovation.
• The Associate Director will be evaluated on their ability to meet key performance indicators and drive operational success.
• Strong leadership skills are necessary to motivate and develop a high-performing laboratory operations team.
• The role requires a balance of strategic planning and hands-on management to ensure daily operations run smoothly.
• Candidates should be prepared to engage with senior leadership on matters related to operational strategy and resource allocation.
• The successful candidate will contribute to the long-term growth and scalability of the laboratory operations function.
• Natera is an equal opportunity employer and encourages diversity in the workplace.
• All requirements stated in this job description are considered essential functions of the job.