Prime Medicine Benefits Overview

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.

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.