Jobs at Elevatebio

Lead master production scheduling, scenario planning, capacity modeling, slot allocation, and S&OP within a biomanufacturing environment. The role aligns demand, supply, manufacturing capacity, inventory, and cross-functional priorities; manages SAP production schedules; tracks KPIs; supports GMP activities, technology transfers, and clinical manufacturing; and drives reporting and continuous improvement across Supply Chain, Manufacturing, Quality, Finance, and Commercial teams.

Perform routine cGMP manufacturing of cell and gene therapy products, including aseptic processing, cell culture, viral vector processing, fill-finish, and inspection. Support manufacturing start-up through SOPs, batch records, reports, risk assessments, and material management. Train team members, maintain cleanroom readiness, manage batch data, and collaborate with process sciences, engineering, quality, and tech operations. Identify improvements in process, safety, quality, and cost while supporting technology transfer and deviation resolution.

Perform routine cGMP manufacturing of cell and gene therapy products, including aseptic processing, cell culture, upstream and downstream processing, cryopreservation, fill-finish, and inspections. Support manufacturing start-up through SOPs, batch records, risk assessments, material management, training, and equipment setup. Collaborate with quality, process sciences, engineering, and technical operations teams on technology transfer, deviations, CAPAs, change controls, and continuous improvement. Work rotating 12-hour shifts with overtime as needed.

Supports outsourced QC testing for cell and gene therapy products, including protocol and data review, laboratory investigations, deviations, sample shipments, inventory, stability programs, change controls, and client documentation. Manages QC sample submission and receipt processes, reviews testing data in LIMS and QMS, and communicates with clients and cross-functional teams. Requires GMP knowledge and flexibility for nights, weekends, holidays, and physical laboratory activities.

Supports the design, programming, commissioning, validation, maintenance, and troubleshooting of industrial automation and control systems in a regulated cell and gene therapy manufacturing facility. Responsibilities include SCADA, PLC, historian, networking, documentation, system testing, vendor coordination, data collection, reporting, equipment integration, tech transfers, and operational support. The role collaborates with Facilities, Engineering, Operations, Quality, and Validation teams and participates in future on-call support.

Lead proactive internal and select external communications for a growing biotech/CDMO organization. Develop communications strategy, advise senior leaders, create executive messaging, manage channels such as town halls and newsletters, oversee corporate communications and PR, measure effectiveness, and lead one communications professional. Partner cross-functionally with People & Culture, Commercial, Marketing, and company leaders to support organizational growth, transformation, and alignment.

Leads Quality Control startup activities for a new Pittsburgh manufacturing facility, including procedures, laboratory systems, training, environmental monitoring, aseptic programs, investigations, data trending, audits, and regulatory inspections. Oversees microbiology function development, tech transfer support, quality systems, outsourcing logistics, and laboratory operations. Hires, trains, and mentors staff while ensuring GMP compliance for clinical and commercial manufacturing.

Develop, optimize, scale, and characterize mRNA production and purification processes. Perform IVT, plasmid DNA linearization, TFF, chromatography, and analytical testing while supporting tech transfer from bench scale to GMP manufacturing. Collaborate with MSAT, analytical development, clients, and business development teams on project execution, proposals, technical communications, SOPs, and regulatory documentation. Preferred experience includes mRNA-LNP formulation, JMP-based DoE, GMP regulations, Quality by Design, and regulatory filings.

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

Perform GMP QC testing for gene and cell therapy programs, including PCR, flow cytometry, ELISA, and cell-based assays. Record and peer-review data, assist with investigations (deviations/CAPAs/OOS), manage inventory and routine lab maintenance, and support assay qualification and procedure drafting.