Jobs at Moderna

Leads Moderna’s analytical innovation strategy, developing and implementing next-generation methods across clinical and commercial products. Oversees technology scouting, proof of concept, method development, validation, transfer, automation, digital integration, and lifecycle adoption across the QC network. Partners with scientific, quality, regulatory, manufacturing, and external teams to modernize analytical workflows, ensure GMP and regulatory compliance, and deliver measurable improvements. Builds external collaborations, develops scientific talent, and drives scalable analytical capabilities for mRNA and advanced therapeutic modalities.

Supports vaccine analytical development, control strategy execution, CMC regulatory submissions, health-authority responses, and Annual Strain Update activities. Authors and reviews filing content, interprets analytical data, coordinates cross-functional SMEs, tracks commitments and risks, and ensures compliance with FDA, EMA, ICH, GMP, data-integrity, and document-control expectations. The role requires strong technical writing, scientific judgment, project execution, and collaboration across analytical, quality, regulatory, manufacturing, and development teams.

Leads the INT Digital portfolio supporting individualized therapy ordering, manufacturing, quality, and delivery. Translates business and technology strategy into roadmaps, coordinates cross-company delivery with Merck, manages governance, dependencies, financials, vendors, and delivery risks, and influences architecture decisions. The role requires technical program management expertise, executive communication, Scrum and delivery telemetry experience, regulated-industry knowledge, and the ability to align distributed engineering, product, manufacturing, quality, regulatory, and operational teams.

Leads analytical method transfers from Analytical Development into ATO and QC laboratories. Responsibilities include readiness assessments, transfer strategy and protocol design, hands-on method execution, analyst training, troubleshooting, root-cause investigations, and method performance improvement. The role supports GMP documentation, deviations, OOS/OOT investigations, CAPAs, change controls, validation, and regulatory requirements while developing standardized transfer practices across analytical platforms and therapeutic modalities.

Leads analytical method development, transfer, qualification, and validation-readiness across Analytical Development, QC, Quality, and technical operations. Troubleshoots complex assay issues, supports investigations, CAPAs, and change controls, interprets analytical datasets, and drives continuous improvement. The role authors technical protocols and reports while ensuring methods meet technical, operational, and regulatory expectations in a GMP or late-stage development environment.

Develop, qualify, validate, and implement ligand-binding and cell-based biomarker and immunogenicity assays for clinical programs. Perform clinical sample testing, data analysis, quality review, documentation, and regulatory compliance activities in a GxP laboratory. Lead quality analytics, data integrity, SOP and controlled-document management, training, audit support, and collaboration with laboratory, quality, biostatistics, and clinical teams.

Supports QC laboratory systems, including LIMS and Chromeleon, through administration, troubleshooting, upgrades, validation, documentation, and user training. Partners with QC, Digital, Automation, IT, and Regulatory teams to implement AI-enabled solutions, improve data review and workflow automation, and ensure GMP, GxP, ALCOA+, quality system, and regulatory compliance.

Owns the design, administration, support, troubleshooting, automation, and optimization of enterprise Linux systems across on-premises and cloud environments. Responsibilities include managing hybrid infrastructure, authentication integrations, containers, storage, monitoring, patching, security hardening, documentation, implementation planning, and incident response. The role supports research and pharmaceutical production systems, participates in on-call rotation, and partners with cybersecurity teams to maintain reliable, scalable, compliant infrastructure.

Leads integrated product lifecycle, commercialization, CMC readiness, supply-chain strategy, manufacturing network planning, launches, regulatory variations, and post-launch performance for pharmaceutical products. Coordinates global cross-functional teams across CMC, Commercial, Regulatory, and Supply Chain, while driving governance, risk management, operational excellence, digital enablement, and Generative AI adoption.

Performs cGMP quality control microbiology testing for mRNA drug substances and products, including sterility, endotoxin, environmental monitoring, growth promotion, and microbial sequencing. Supports method qualification, stability programs, data trending, investigations, OOS results, deviations, CAPA, equipment maintenance, inventory, and GMP documentation. Uses LabVantage LIMS and electronic assay forms while maintaining data integrity, inspection readiness, and laboratory compliance.

Leads hands-on antibody discovery and protein engineering programs from library design and yeast-display selection through characterization, optimization, and lead identification. Designs complex molecular biology and protein engineering experiments, analyzes sequence and NGS data, and evaluates antibody binding, specificity, stability, expression, developability, and function. Partners with computational, structural, bioinformatics, and antigen-design teams to execute iterative design-build-test-learn workflows, troubleshoot challenges, communicate findings, and mentor junior scientists.

Performs GMP quality control activities for raw materials and drug products, including sampling, testing, inspection, release, shipping, retain sample management, and LIMS documentation. Uses HPLC, Bioanalyzer, spectroscopy, osmolality, pH, conductivity, and visual inspection methods. Maintains controlled-temperature units, supports investigations and quality systems records, writes SOPs and reports, and follows cGMP, GxP, aseptic, data integrity, and safety requirements in a fully onsite laboratory.

Performs cGMP drug product manufacturing operations, including formulation, sterile filtration, aseptic filling, visual inspection, material staging, equipment checks, and in-process controls. Completes compliant documentation in MES and electronic batch records, escalates deviations, supports investigations and SOP improvements, and collaborates with QA, QC, Facilities, Supply Chain, and other teams. Requires cleanroom gowning, extended standing, lifting, night-shift availability, and flexibility for overtime, weekends, and holidays.

Lead the design, operation, and optimization of enterprise infrastructure automation across cloud, hybrid, on-premises, and network environments. Develop Infrastructure-as-Code using Ansible, Terraform, CloudFormation, ARM templates, Bicep, and scripting languages. Support CI/CD, monitoring, compliance, troubleshooting, and network integrations while mentoring engineers and improving operational reliability, security, and consistency.

Performs cGMP in-process, release, and stability testing for pharmaceutical materials and products. Uses analytical laboratory equipment, documents results in LIMS and assay worksheets, maintains data integrity, supports investigations and CAPAs, troubleshoots methods and equipment, manages samples and laboratory supplies, maintains equipment and housekeeping, and revises SOPs and protocols. The role is fully onsite and may support special projects.

Performs routine analytical chemistry testing for release, stability, and in-process pharmaceutical products. Supports method qualification, troubleshooting, equipment maintenance, data entry, trending, stability programs, and LIMS activities. Maintains cGMP documentation and contributes to deviations, change controls, CAPAs, laboratory procedures, and audit readiness while following GxP, data integrity, and safety requirements.

Performs analytical chemistry testing and QC data review for clinical and commercial products, including release, stability, and in-process testing. Supports method qualification, troubleshooting, equipment maintenance, trending, LIMS entry, stability programs, and laboratory documentation. Authors quality-system records and procedures while maintaining cGMP, GxP, data integrity, and safety compliance. The role is fully onsite and may require shift flexibility for manufacturing support.

Performs routine analytical chemistry testing and reviews release, stability, and in-process data for clinical and commercial products. Supports method qualification, troubleshooting, stability programs, manufacturing STAT testing, LIMS data entry, laboratory operations, equipment maintenance, and procedure authoring. Maintains cGMP documentation, supports deviations, change controls, and CAPAs, and follows GxP, data integrity, safety, and audit-readiness requirements in a fully onsite laboratory environment.

Performs cGMP quality control chemistry testing for release, stability, and in-process samples using chromatographic and analytical techniques. Maintains laboratory operations, enters results in LabVantage LIMS, supports data trending, equipment troubleshooting, documentation, SOPs, investigations, deviations, CAPAs, and quality systems records. Provides training and data-review support to junior staff while maintaining compliance with GxP, data integrity, and safety requirements.

Leads CMC product lifecycle management, commercialization, launch readiness, supply chain strategy, manufacturing network resilience, regulatory variations, packaging, and post-launch performance for mRNA medicines. Coordinates cross-functional teams across CMC, Commercial, Regulatory, and Supply Chain; establishes governance, manages risks and KPIs, oversees global expansion and lifecycle changes, and drives operational excellence and continuous improvement.