Project Specialist I, Manufacturing

The role

This person will support technical documentation, quality records, training, and improvement projects for the manufacturing team. They will also own short-term manufacturing scheduling and resource planning to ensure teams are staffed and aligned to production schedules.

What you will do

• Support quality and technical documentation including Discrepancies, Deviations, CAPAs and Change Controls
• Generate and revise SOPs, batch records and other documents
• Support cleanroom operations including maintenance, cleaning, and document review
• Develop and maintain short-term manufacturing schedules and resource planning
• Partner with Supply Chain Planner to align on batch schedules
• Monitor resource availability and adjust assignments for changes or absences
• Maintain the manufacturing training matrix and coordinate onboarding for new technicians
• Track training completion and qualification status
• Support implementation of Operational Excellence programs
• Facilitate communication between manufacturing supervisors and Supply Chain Planning

Required qualifications

• 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 with manufacturing scheduling, resource planning, or workforce coordination
• Proficiency in Microsoft Office Suite, especially Excel
• 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 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

Nice to have

• Experience in autologous gene or cell therapy is a plus
• 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)

About the company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization.