About the Job

The Lab Operations Process Support Manager is a key member of the Laboratory Operations Team at Foundation Medicine and provides onsite assay technical support and leads process optimization for Next Generation Sequencing (NGS) based clinical assays with a focus spanning from sample receipt through sample sequencing, driving continuous improvement, troubleshooting, and quality investigations. Responsibilities include managing non-conformances and CAPAs, conducting root cause analysis and investigations, analyzing performance metrics, supporting internal and external inquiries, and collaborating cross-functionally to enhance workflow efficiency and resolve issues. The position also contributes to audit readiness, documentation, and strategic initiatives, serving as a subject matter expert in laboratory processes and instrumentation. This position works in a lab environment around the presence of chemicals and reagents.

Key Responsibilities

• Initiate, execute and direct investigations and problem solving for laboratory and department incidents, including writing or reviewing non-conformance reports, deviations, Corrective Action and Preventative Actions (CAPAs), or incident reports and communicate findings to stakeholders across the organization.
• Conduct root cause analysis and investigations to support corrective and preventative actions and non-conformance corrections.
• Support performance questions related to metrics such as turnaround time, volumes, and failure rates.
• Lead continuous improvement efforts by identifying process performance issues and determining pathways for improvements and specifying requirements for tools to enhance workflow efficiency and robustness, and in planning to implement solutions.
• Provide answers to internal and external inquiries related to the technical aspects of sample processing and support resolutions.
• Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed.
• Build consensus with stakeholders across the organization based on scientific understanding, data analysis and operational findings when required.
• Author technical and scientific sections of various QMS documentation (CAPA, NCR, etc.) based on Quality and Regulatory frameworks (CAP, CLIA, ISO, FDA).
• When negative trends are identified in performance data, drives investigations, decision making and insights.
• Represent laboratory operations department at cross functional meetings as needed.
• Make technical decisions that can have an impact across Lab Ops organization in conjunction with the clinical laboratory director.
• Serve as a SME for the Lab Ops organization.
• Hold a technical leadership role on project teams and organizational initiatives.
• Make technical decisions that impact the Lab Operations organization while serving as a strategic point of contact and decision support in collaboration with the Technical Supervisor / Clinical Laboratory Director.
• Assist in preparing for, performing and responding to internal and external audits as well as any other inspections.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s of Science Degree in a chemical, physical or biological science
• 5+ years experience in a molecular clinical laboratory
• 4+ years of experience in Next Generation Sequencing with an emphasis on processing logistics
• 4+ years of sample and study processing management
• Demonstrated deep understanding of FDA, CAP/CLIA, ISO regulations

Preferred Qualifications

• Master’s degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.)
• 5+ years of proven leadership experience
• Strong experience with DNA/RNA extraction and library construction methodologies
• Strong experience with target-enrichment approaches such as hybrid capture and multiplex PCR
• Experience driving the systematic optimization and troubleshooting of complex molecular diagnostic and NGS-based assays through integration of information related to the input sample, lab processes and data analysis pipeline
• Expertise creating and optimizing robust protocols for use in high throughput laboratory automation systems
• Familiarity with high through-put platforms and common molecular laboratory equipment
• (pipettes, automated liquid handlers, sequencers, etc.)
• Formal training and experience operating in a Laboratory Information Management Systems (LIMS)
• Maintaining and ensuring compliance with a Quality Management System
• Experience utilizing tools such as RCA, SPC and LEAN frameworks to drive improvements to process and aid in investigations.
• Understanding and Application of Quality and Regulatory requirements of governing bodies (CAP, CLIA, ISO, FDA)
• Demonstrated experience using various Statistical and Analytics approaches to assess performance
• Demonstrated history of work in a fast-paced environment with changing and competing priorities
• Excellent time management, organizational capabilities and attention to detail
• Strong communication skills, demonstrated by a history of complex technical information sharing to internal and external stakeholders in various formats including reports, presentations and publications
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.