The RoleElevateBio 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 DoTechnical 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
- 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 support supervisors in planning requalification and continuing education activities
Operational Excellence & Continuous Improvement- 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
Cross-Functional Coordination- 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 years 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
Physical and Environment Requirements:- Ability to stand, walk, bend and stretch for extended period 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
The budgeted range for this position is $90,000 - $120,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
