Jobs at Elevatebio

The Associate I, QC Microbiology performs routine microbiological assays, environmental monitoring, data entry, and supports quality events in a GMP environment.

Support QC Microbiology testing and cleanroom operations including routine microbial assays, environmental and utilities monitoring, data entry into LIMS/QMS/CMMS, leading investigations and minor quality events, supporting CAPAs/change controls/OOS, revising test methods/SOPs, and assisting training to ensure GMP compliance and timely completion of testing.

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

Perform routine QC microbiology assays and environmental/utility monitoring for cell therapy products under cGMP. Execute sterility, bioburden, endotoxin, TOC/conductivity testing, LIMS data entry and peer review, equipment PMs, and support investigations, deviations, CAPAs, and change controls in cleanroom environments.

Perform and lead routine cGMP manufacturing of cell and gene therapies (aseptic processing, cell culture, upstream/downstream, fill/finish). Author batch records and SOPs, train staff, maintain cleanrooms, support tech transfers with cross-functional teams, manage batch data, and drive continuous improvement in safety, quality, and process efficiency.

Perform routine right-first-time cGMP manufacturing for cell and gene therapies (aseptic processing, cell culture, cryopreservation, upstream/downstream, fill/finish). Maintain SOPs/batch records, support equipment/setup, lead training, partner with QA/MSAT to resolve deviations and CAPAs, execute batch reviews and continuous improvement to ensure safety, quality, and scale-up readiness.

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.

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.

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.

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

The Biomanufacturing Associate I will perform routine cGMP manufacturing of cell and gene therapy products, including aseptic processing and support continuous improvement in operations and safety standards.

The Biomanufacturing Associate I will perform routine cGMP manufacturing for cell and gene therapies, participate in operations start-up, support quality assurance, and contribute to process improvements in a dynamic environment.