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We are seeking an execution-driven, scientifically-grounded leader to establish and operationalize Moderna’s centralized Bioassay Center of Excellence (CoE), a transformative initiative focused on building high-throughput, GxP-ready bioassay capabilities across the portfolio. Based onsite at our Norwood, MA Technology Center, the Director will lead daily bioassay operations while driving the design, implementation, and scale-up of a fully automated centralized facility. The role demands a strategic systems thinker who can convert complex assay science into scalable operations that power product characterization, release, and stability testing. This is a deeply cross-functional position, interfacing across Analytical Development, QC, Automation Engineering, Quality, and external partners to ensure robust and compliant execution. It also offers a unique opportunity to engage directly with Moderna’s digital and automation landscape—including exposure to Generative AI-enabled lab systems—helping shape the future of data-rich decision-making in bioprocessing.
Job Responsibility:
Build, lead, and develop a high-performing multidisciplinary bioassay operations team, including scientists, automation technologists, analysts, and supervisors
Oversee execution of critical assay types such as IVRPE, IVRPA, and REDA supporting stability, release, and characterization
Define and own key operational metrics (e.g., throughput, TAT, % automation coverage, assay reproducibility, cost per result) and drive continuous improvement
Implement and govern GxP-ready infrastructure across SOPs, ELN templates, LIMS integration, barcoding, and sample chain-of-custody workflows
Execute workforce planning, recruiting, and training strategies aligned to the scale and complexity of automated operations
Serve as bioassay and operations lead in the design, build, and launch of the centralized Bioassay CoE, including facility input, equipment selection, FAT/SAT planning, validation, and Go-Live
Lead cross-functional integration with Quality, Facilities, Automation Engineering, Analytical Development, IT, Supply Chain, and EHS to ensure scope alignment, risk mitigation, and on-time delivery
Develop and implement the operating model that supports flexible deployment of GMP and non-GMP testing within shared lab space
Collaborate with automation and digital teams to embed next-generation tools, including opportunities to incorporate Generative AI capabilities for smarter lab operations and enhanced data analytics.
Requirements:
Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
15 years of relevant experience with Bachelor’s degree or 10 years of relevant experience with a PhD.
Nice to have:
PhD in a relevant field
Substantial hands-on experience leading bioassay operations, bioanalytical laboratories supporting cell-based or biological assays, or centralized CoE / high-throughput bioassay facilities
Strong people leadership experience, both direct management and matrixed across scientists, automation engineers, and operations staff
Experience in delivering complex capital automation projects in a regulated environment (capital project ownership, equipment selection, vendor management, FAT/SAT, IQ/OQ/PQ)
Familiarity with automated liquid handling, plate readers, imaging systems (Incucyte/Vi-CELL or equivalents), LIMS/MES integrations, and assay data pipelines
Working knowledge of GxP, GMP/GCLP, and regulatory expectations for assay validation and laboratory compliance
Experience with cell culture automation, cell banking best practices, and process controls to minimize biological drift (passage control, viability gating and automated quarantine workflows)
Experience partnering with Quality, QC, Analytical Development, and Regulatory to deploy validated assays for program decision-making and filing
Strong track record of cross-functional influence, stakeholder management, and delivering operational metrics improvements (throughput, cost, quality).
What we offer:
Best-in-class healthcare coverage, plus voluntary benefit programs
Holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown