Sample Management Manager

About the role

As the Sample Management Manager, you will oversee the complete lifecycle of clinical diagnostic samples within Natera's R&D operations. This includes biobanking, cold chain logistics, and ensuring all processes meet strict regulatory and quality standards for cell-free DNA testing. You will guide a team to optimize workflows and use data to maintain accuracy in a clinical setting.

Key facts

What you'll do

• Create and implement standard procedures for sample intake, storage, tracking, and distribution.
• Ensure strict adherence to regulatory guidelines (e.g., GMP, GLP, ISO) and company policies.
• Manage Laboratory Information Management Systems (LIMS) to maintain sample integrity and traceability.
• Lead, train, and develop the Sample Management team for precise execution.
• Collaborate with R&D, Quality, Supply Chain, and external partners to align sample management practices.
• Use data to identify and resolve discrepancies, logistical issues, and quality concerns.
• Evaluate workflows with data and implement technology improvements for precision and scale.
• Prepare reports and audits for quality assurance and regulatory inspections.
• Take charge of sample management operations, allocating resources and designing workflows to meet clinical timelines.
• Provide clear guidance, establish policies, and remove operational bottlenecks.
• Address operational challenges using data to resolve workflow and capability gaps.
• Manage team scheduling, performance metrics, and operational budgets.
• Advise the team and directly assist with issue resolution and technical troubleshooting.
• Ensure team members precisely follow SOPs and safety procedures.
• Oversee new hire training and cultivate an execution-focused culture.
• Conduct regular one-on-one meetings for data-backed performance evaluations and goal discussions.
• Plan and lead shift meetings to promote team alignment and professionalism.
• Approve timecards, PTO requests, and ensure consistent staffing.
• Dynamically prioritize workloads, delegate responsibilities, and escalate issues.
• Ensure all regulatory agency requirements are met through documentation, audits, and corrective actions.
• Maintain strict compliance with HIPAA/PHI privacy policies and complete required training within 30 days of hire.
• Oversee sample processing, ensuring accurate documentation and adherence to departmental expectations.
• Support R&D leadership in initiating projects to improve operational efficiency.

Requirements

• Bachelor's degree in Medical Technology, Biological Sciences, or a related field.
• 8+ years of relevant experience with a bachelor's degree.
• Minimum 3 years of team management experience.
• Demonstrated team management in a fast-paced, regulated environment.
• Ability to manage projects independently with an ownership approach.
• Clear, direct communication and troubleshooting skills.
• Excellent pipetting, data analysis, and wet lab operations abilities.
• Proficiency in Laboratory Information Management Systems (LIMS) and data analysis tools.
• Experience with Molecular Biology, Good Manufacturing Practice (GMP), and Quality System Regulation (QSR).
• Strong Excel and data management software experience.
• Ability to analyze and improve operational processes for efficiency and compliance using data.

Nice to have

• Master's degree preferred.
• Experience with biorepository sample management.
• Strong knowledge of regulatory requirements in sample handling.

Skills & tools

• LIMS
• Excel
• Data analysis tools
• Molecular Biology
• GMP
• QSR

Practical notes

Natera offers comprehensive benefits including medical, dental, vision, life, and disability plans. Employees and their immediate families receive free testing and fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k, and commuter benefits. Natera will only contact candidates from a @natera.com email domain.