Sample Management Manager

POSITION SUMMARY:  

Join Natera’s R&D operations as the Sample Management Manager. You will direct biobanking, cold chain logistics, and the full lifecycle of clinical diagnostic samples. Every sample represents a real person, and you will ensure that tracking, storage, and distribution meet the rigorous standards required to advance cell-free DNA testing. You will lead a high-performing team, optimizing workflows and using data to maintain accuracy and regulatory adherence in a high-stakes clinical environment.

PRIMARY RESPONSIBILITIES:

• Develop and implement standardized procedures for sample intake, storage, tracking, and distribution
• Treat regulatory guidelines (e.g., GMP, GLP, ISO) and company policies as the foundation of your work, ensuring strict compliance
• Manage Laboratory Information Management Systems (LIMS) to maintain sample integrity and traceability
• Lead, train, and develop the Sample Management team to operate with pace and precision
• Think team by partnering directly with R&D, Quality, Supply Chain, and external partners to align sample management practices without needing translation layers
• Use data to troubleshoot discrepancies, root-cause logistical issues, and resolve quality concerns
• Use data to pressure-test workflows and implement technology enhancements that improve precision and scale
• Prepare rigorous reports and audits to support quality assurance and regulatory inspections

Operational Responsibilities

• Take ownership of sample management operations, proactively allocating resources and designing workflows to meet rigorous clinical timelines
• Provide clear guidance to the team, establishing policies and removing operational bottlenecks without relying on heavy hierarchy
• Take ownership of operational challenges, relying on data rather than opinion to resolve workflow and capability gaps
• Manage scheduling, performance requirements, and operational budgets
• Act as an advisor to the team, directly stepping in to assist with issue resolution and technical troubleshooting

Team & Performance Management

• Direct team members to ensure precise execution of SOPs and safety procedures
• Oversee training for new hires and build an execution-focused culture
• Conduct regular 1:1 meetings to deliver unvarnished, data-backed performance evaluations and discuss goals
• Plan and lead shift meetings, fostering team alignment and professionalism
• Approve timecards, PTO requests, and ensure consistent staffing coverage
• Prioritize workloads dynamically, delegate responsibilities, and escalate issues without hesitation

Compliance & Quality Assurance

• Treat quality as part of performance by ensuring all regulatory agency requirements are met through proper 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 and executing new projects to enhance operational efficiency

QUALIFICATIONS:

• BS/BA degree (Master’s degree preferred) in Medical Technology, Biological Sciences, or a related field
• 8+ years of related experience with a bachelor’s degree
• Minimum 3 years of team management experience

KNOWLEDGE, SKILLS, AND ABILITIES:

• Demonstrated team management experience in a fast-paced, regulated environment
• Ability to manage projects independently with an ownership mindset
• 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
• Experience with biorepository sample management is a plus
• Strong knowledge of regulatory requirements in sample handling is preferred