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Director, Technical Development Operations

Moderna

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Location:
United States , Norwood

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Contract Type:
Employment contract

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Salary:

167000.00 - 300700.00 USD / Year

Job Description:

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
  • Savings and investment opportunities
  • Location-specific perks and extras

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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