Moderna · 10 hours ago
Director, Technical Development Operations
Norwood, MA
Full-time
Onsite
Director/Executive
$167K/yr - $301K/yr
10+ years expModerna is a pioneering company revolutionizing medicine through mRNA technology, seeking a scientifically-grounded leader for their Bioassay Center of Excellence. The Director will lead bioassay operations, drive design and implementation of automated facilities, and ensure compliance across Analytical Development and Quality teams.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
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
Qualification
Required
Education: Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
Experience: 15 years of relevant experience with Bachelor's degree or 10 years of relevant experience with a PhD
Preferred
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)
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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-24
legacy.thefly.com
2026-01-23
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