Director, Technical Development Operations

ModernaNorwood, MA
4d$167,000 - $300,700Onsite

About The Position

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. 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.

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 Haves

  • PhD in a relevant field is preferred.
  • 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).

Responsibilities

  • 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.

Benefits

  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A 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 to help you plan for the future
  • Location-specific perks and extras
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