Product Implementation Initiatives Senior Lead in Morrisville, North Carolina at Foundation Medicine, Inc.

About the Job:

The Product Implementation Initiatives Lead plays a critical role in advancing and operationalizing strategic laboratory initiatives across the FlexOMx portfolio. This role goes beyond traditional project execution, serving as the end-to-end owner for complex, cross-functional initiatives that must scale from concept or pilot into sustainable, multi-site laboratory operations.

This position partners closely with laboratory leadership, site operations, scientific teams, quality, informatics, and other cross-functional stakeholders to ensure initiatives are not only delivered, but fully integrated into business-as-usual operations. The Initiatives Sr. Lead is accountable for tracking progress against defined success metrics, proactively identifying barriers, assessing operational readiness, and driving resolution of risks that could impact adoption, scalability, or performance.

A core focus of this role is supporting site-to-site scale-up and operationalization of assays, workflows, and laboratory capabilities across FMI locations. This includes evaluating site readiness, aligning resources and quality requirements, standardizing implementation approaches where appropriate, and ensuring durable handoffs to site operational owners. The role emphasizes transforming strategic initiatives into repeatable, scalable operating models that enable growth, innovation, and consistency across the organization.

This role is considered an essential onsite role with the potential for flexible work from home options in certain situations.

Key Responsibilities:

• Initiative & Portfolio Ownership :
  • Serve as end-to-end owner for assigned FlexOMx initiatives , accountable for for operational readiness, adoption, scalability, and sustained performance across laboratory sites.
  • Translate strategic objectives into durable operating models, ensuring initiatives mature beyond pilot or launch phases into repeatable, scalable laboratory operations.
  • Own initiative success metrics , including readiness criteria, scalability milestones, operational KPIs, and post-implementation performance tracking.
  • Project Execution Oversight : Drive the execution of laboratory initiatives within FlexOMx, monitoring progress, identifying and resolving roadblocks, and ensuring adherence to project plans and quality standards.
  • Cross-Functional Collaboration: Partner effectively with laboratory heads, research scientists, operations teams, IT, project management, and other stakeholders to ensure alignment and effective communication throughout the project lifecycle.
  • Communication and Reporting: Prepare and deliver regular project status updates to stakeholders, highlighting progress, risks, and potential delays. Develop clear and concise reports on project outcomes and impact.
  • Documentation: Maintain comprehensive project documentation, including plans, timelines, reports, and lessons learned.
• Operationalization & Scale-Up Leadership :
  • Lead site-to-site scale-up of assays, workflows, and laboratory capabilities, ensuring consistent implementation, validation readiness, quality alignment, and operational sustainability across FMI locations.
  • Assess site readiness and constraints (people, equipment, space, informatics, quality systems) and develop mitigation strategies to enable successful deployment.
  • Drive standardization where appropriate while allowing for site-specific variability required by infrastructure, regulatory scope, or operational context.
  • Partner with site leadership to embed initiatives into business-as-usual operations , including training, documentation, handoffs, and operational ownership models.
  • Operationalize and Scale up small scale niche assays at other FMI sites to support Biopharma partners and innovative initiatives.
• Cross-Site Enablement & Capability Building :
  • Establish scalable implementation frameworks (playbooks, readiness checklists, success criteria) to enable repeatable deployment of assays and workflows across FMI sites.
  • Support workforce enablement during scale-up, including onboarding plans, competency alignment, and knowledge transfer to ensure long-term site independence.
  • Mentor and guide team members and rotation participants within Product Implementation with an emphasis on initiative ownership, systems thinking, and operational leadershipbuilding future leaders rather than task executors.
  • Provide mentorship and day to day guidance for rotation participants.
• Other projects and duties as assigned.
• Travel may be required up to 20% to other FMI sites to lead assay enablement and operationalization.
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelors of Science Degree in a chemical, physical or biological science
• 5+ years experience in a molecular clinical laboratory
• 3+ years of experience in Next Generation Sequencing with an emphasis on processing logistics
• Demonstrated deep understanding of FDA, CAP/CLIA, ISO regulations
• Demonstrated success in leading and executing complex projects with cross-functional teams.

Preferred Qualifications:

• Masters degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) 4+ years of proven leadership experience Strong experience with DNA/RNA extraction and library construction methodologies
• 1+ years of management experience
• 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 patient safety and data privacy regulations and guidelines
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $120,720 - $150,900 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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