Project Specialist

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role

ElevateBio is looking for a Project Specialist I, Manufacturing that will support aspects of technical documentation, quality records, training, improvement projects and compliance for our manufacturing team and broader facility. In addition to core project specialist responsibilities, this role will own short-term manufacturing scheduling and resource planning, ensuring manufacturing teams are appropriately staffed, trained, and aligned to execute production schedules efficiently. The ideal candidate is detail-oriented, collaborative, and thrives in a fast-paced GMP manufacturing environment.

Here’s What You’ll Do

Technical Documentation & Quality Support:

• Support of quality and technical documentation for manufacturing including Discrepancies and/or Deviations, CAPAs and Change Controls (including initiation, investigation, root cause analysis with cross functional groups and closure)
• Generate and revise Standard Operating Procedures (SOPs), batch records and other documents to support manufacturing processes and programs
• Support cleanroom operations including cleanroom maintenance and cleaning, and executed batch record and document review, as applicable

Scheduling & Resource Planning

• Develop and maintain short-term manufacturing schedules, assigning technicians and resources to batch production activities across teams
• Partner with the Supply Chain Planner to align on batch schedules, translating production plans into daily and weekly technician assignments
• Monitor resource availability and proactively adjust assignments to accommodate schedule changes, absences, and shifting priorities
• Maintain visibility into staffing levels across manufacturing teams, identifying gaps and escalating resource constraints as needed
• Serve as the primary scheduling point of contact within Manufacturing Technical Operations, ensuring alignment between production schedules and workforce availability

Training Coordination & Oversight

• Own and maintain the manufacturing training matrix, ensuring technician training records are current and aligned with role requirements
• Coordinate onboarding schedules for new manufacturing technicians in partnership with supervisors, ensuring timely completion of required training