Project Specialist I, Manufacturing

About the role

ElevateBio is looking for a Project Specialist I, Manufacturing to support technical documentation, quality records, training, improvement projects and compliance for the manufacturing team and broader facility. The role also owns short‑term manufacturing scheduling and resource planning, ensuring teams are appropriately staffed, trained, and aligned to execute production schedules efficiently.

Responsibilities

• Support quality and technical documentation for manufacturing including discrepancies/deviations, CAPAs and change controls (initiation, investigation, root cause analysis with cross‑functional groups and closure).
• Generate and revise SOPs, batch records and other documents to support manufacturing processes and programs.
• Support cleanroom operations including cleanroom maintenance and cleaning, and execute batch record and document review as applicable.
• 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.
• 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 with supervisors, ensuring timely completion of required training.
• Track training completion and qualification status, flagging gaps that may impact scheduling or production readiness.
• Support delivery of technical and quality training to the manufacturing team and assist supervisors in planning requalification and continuing education activities.
• Support implementation of Operational Excellence programs driving efficiencies in execution and across the site.
• Track and report on scheduling adherence, resource utilization, and training completion metrics.
• Develop and maintain scheduling tools and reports to improve visibility into workforce planning and resource allocation.
• Identify opportunities to improve scheduling processes, training coordination workflows, and cross‑team communication.
• Facilitate communication between manufacturing supervisors, the Supply Chain Planning team, and other stakeholders regarding schedule updates and resource changes.
• Participate in scheduling and planning meetings, providing input on resource capacity and technician availability.
• Proactively identify and resolve scheduling conflicts, working collaboratively with supervisors and planners to maintain production continuity.
• Support project team environment with project deliverables.

Requirements

• Bachelor’s degree and at least 3 years of related experience, OR Master’s degree with at least 1 year of related experience.
• Experience in a Manufacturing, Technical Operations, or GMP environment.
• Experience in autologous gene or cell therapy is a plus.
• Experience with manufacturing scheduling, resource planning, or workforce coordination.
• Proficiency in Microsoft Office Suite, especially Excel, for scheduling, tracking, and reporting.
• Experience working in autologous gene or cell therapy and within a contract manufacturing or client service organization is strongly preferred.
• Familiarity with manufacturing/quality architectures and systems (e.g., SAP, electronic batch records, Veeva).
• Strong attention to detail, time management skills, and ability to work in a fast‑paced environment.
• Ability to stand, walk, bend and stretch for extended periods of time.
• Ability to lift 25‑50 lbs.
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands.

Pay

The budgeted range for this position is $90,000 - $120,000.