Associate Director, Device Manufacturing
About The Position
The Associate Director, Device Manufacturing is responsible for establishing and leading the internal device manufacturing function within Foundation Medicine's Global Supply Chain & Device Manufacturing organization. This is a foundational leadership role created to build the team, systems, and quality infrastructure required to support compliant, scalable, and reliable tech transfer and commercial production of FMI's internally manufactured IVD reagent and consumable kit products. The Associate Director will define and operationalize FMI's manufacturing operating model, establish GMP- and GDP-aligned procedures and documentation frameworks, and drive the organization toward best-practice regulatory compliance under 21 CFR Part 820 / QMSR and ISO 13485. This individual will serve as the primary manufacturing voice across Quality, Supply Chain, Regulatory Affairs, and Laboratory Operations, ensuring that production activities are aligned with FMI's commercial supply objectives and its mission to transform cancer care.
Requirements
- Bachelor’s Degree in a life science field or equivalent experience
- 8+ years of high complexity testing experience in a CLIA regulation-adherent lab
- 4+ year of management experience
Nice To Haves
- Master’s of Science in Bioinformatics, Biology, or a related scientific field
- 3+ years of experience managing high complexity testing in a CLIA-adherent lab
- Strong knowledge of cancer genetics
- Experience with Next-Generation Sequencing
- Substantive genomics research experience in rigorous academic setting
- Experience with bioinformatics tools and databases (NCBI, UCSC Genome Browser, IGV)
- Scripting ability in Python or Perl
- Facility with UNIX environment
- Experience working within a CLIA certified clinical diagnostics laboratory
- Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
- Excellent organization and attention to detail
- Understanding of HIPAA and the importance of patient data privacy
- Commitment to reflect FMI’s values: Integrity, Courage, and Passion
Responsibilities
- Establish and lead the Device Manufacturing team, initially through management of direct reports transitioning into the newly formed function; develop team structure, staffing model, and capability roadmap to support commercial manufacturing at scale
- Define roles, responsibilities, and performance expectations for manufacturing personnel; recruit, onboard, mentor, and develop staff in alignment with FMI's values and operational goals
- Foster a culture of quality, continuous improvement, and operational accountability across all manufacturing activities
- Own end-to-end manufacturing operations for internally produced IVD reagent and consumable kit products, including finite production scheduling, batch execution, yield optimization, and supply continuity planning
- Lead development, implementation, and continuous improvement of manufacturing processes, SOPs, batch records, and work instructions to ensure robust, reproducible, and compliant production
- Establish and monitor key performance indicators (KPIs) for manufacturing efficiency, quality, throughput, delivery, and cost; leverage data and analytics platforms — including Python-based tools and Power BI dashboards — to provide executive-level visibility into operational performance and batch progress
- Partner with Supply Chain leadership to align production supply planning with demand forecasting, inventory management, and distribution requirements
- Establish and mature FMI's GMP and GDP operational infrastructure for internal device manufacturing, including documentation systems, change control, deviation management, CAPA, and risk assessment frameworks
- Ensure manufacturing operations comply with applicable regulatory requirements including 21 CFR Part 820 / QMSR, ISO 13485, and relevant FDA guidance for IVD device manufacturers; proactively identify compliance gaps and drive remediation strategies that elevate FMI's regulatory posture to industry best-practice standards
- Lead or support internal audits, FDA interactions, and quality management reviews; serve as the manufacturing subject matter expert in regulatory submissions and responses related to manufacturing operations
- Partner with Quality Assurance to drive best practices in GMP documentation, personnel training, and facility compliance
- Serve as the manufacturing representative in cross-functional program teams, contributing to CMC strategy, product launch readiness, and commercial supply planning
- Collaborate with Regulatory Affairs on device submissions, labeling requirements, UDI compliance under 21 CFR Part 830, and FDA queries related to manufacturing operations
- Partner with Finance and Program Management to develop and manage manufacturing budgets, track operational expenditures, and support strategic make-versus-buy analyses
- Represent Device Manufacturing as a core member of the Global Supply Chain & Device Manufacturing leadership team; contribute to organizational strategy and senior leadership forums
- Other duties as assigned
- Must comply with FMI's attendance policies: Regular onsite work at designated FMI location is an essential function of this role
- Comply with FMI's attendance policies
Benefits
- 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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What This Job Offers
Job Type
Full-time
Career Level
Manager
