Jobs at Prime Medicine

Provides operational quality support for GxP software, equipment qualification, calibration, preventive maintenance, and vendor oversight. Executes software assurance and IQ/OQ/PQ activities, reviews controlled records, maintains CMMS and calibration documentation, coordinates service activities, conducts risk-based supplier assessments, supports audits, and tracks deviations, CAPAs, change controls, and corrective actions through closure. Requires strong documentation, technical writing, organization, and cross-functional coordination in a regulated life-sciences environment.

Hands-on discovery scientist designing and optimizing mRNA architectures for Prime Editing systems. Lead structure-function experiments, drive platform-level innovations, partner with cross-functional teams and CROs, and translate discoveries into program candidates while mentoring junior staff and contributing to publications and patents.

Provide technical leadership for development, characterization, and scale-up of lipid nanoparticle (LNP) formulation and drug-product manufacturing processes. Drive process optimization, analytical characterization, GLP/GMP scale-up, and technology transfer to CDMOs. Support CMC regulatory documentation, maintain ELN records, author SOPs and reports, and communicate results cross-functionally to advance clinical programs.

Build and operate Prime Medicine's scientific data and computing platform: ingest NGS and lab system data into AWS, provide provenance, storage, observability, APIs/SDKs, orchestration for pipelines, AI-enabled internal tooling, and integrations between ELNs/LIMS, instruments, and cloud compute.

Serve as senior biostatistics leader providing study design, statistical methodology, regulatory interaction, and operational oversight for biometrics (biostatistics, data management, vendor programming) across gene editing clinical programs. Build and lead an integrated Biometrics function, manage CRO/vendor relationships, ensure data quality/CDISC standards, support regulatory submissions, and drive inspection readiness and SOPs.