Jobs at Elevatebio

Perform routine cGMP manufacture of cell and gene therapies (CAR-T, iPSCs, AAV, LV), operate bioreactors and downstream equipment, author SOPs and batch records, train staff, maintain cleanrooms, collaborate with QA/QC and process sciences, and drive process, safety, and quality improvements.

Operate and maintain ElevateBio's AWS environment, administer Linux and Windows systems, support networking, contribute to AWS CDK infrastructure-as-code, manage contractors, incorporate AI tools into operations, maintain runbooks and documentation, and collaborate with security and science teams while growing responsibilities.

Support QC logistics and outsourced analytical testing for cell and gene therapy materials: review protocols and data, manage sample submission and inventory, author stability protocols and client documents, review investigations/deviations, coordinate shipments, and communicate with clients and cross-functional teams.

Provide MSAT process science support for GMP manufacturing, technology transfers, validation, and continuous improvement across cell and gene, mRNA, and viral vector programs. Author and review technical documentation, investigate deviations/CAPAs/Change Controls, perform root-cause analyses, support data collection, risk assessments, and cross-functional tech transfer activities during a 6-month contract.

Perform routine right-first-time cGMP manufacturing of cell and gene therapy products (aseptic processing, cell culture, upstream/downstream, cryopreservation, fill/finish). Execute and review batch records/SOPs, support equipment setup, training, CAPA/change control resolution with QA/MSAT, and identify improvements to safety, quality, delivery, and cost. Work rotating 12-hour shifts.

Lead modernization and ownership of Quality Management Systems (eQMS, DMS, LMS) across clinical-to-commercial operations. Drive digital transformation, AI-enabled analytics, inspection readiness, audits/inspections, system integration (SAP, LIMS, MES), governance, adoption, and continuous improvement to ensure Part 11/Annex 11/CSA compliance and measurable operational value.

Lead strategy and operations for gene editing services, overseeing client scientific support and internal R&D. Manage teams, budgets, KPIs, technology development (gRNA design, delivery, NGS analytics), regulatory/IP strategy, and cross-functional alignment to deliver custom genome engineering solutions.

ElevateBio is seeking passionate individuals for various roles to support cell and gene therapy development and innovation.