Project Specialist I, Manufacturing
Core
Support technical documentation, quality records, training, and short-term manufacturing scheduling/resource planning for a GMP manufacturing team.
Role type
Manufacturing Project Specialist
Builds
Production schedules and resource allocation plans for advanced therapy manufacturing
Domain
Biotechnology / Cell & Gene Therapy Manufacturing
Required skills
GMP manufacturing experience, manufacturing scheduling, resource planning, technical documentation (SOPs, batch records), CAPA/Change Control, training coordination, Microsoft Excel
Preferred skills
Autologous gene or cell therapy experience, contract manufacturing experience, familiarity with SAP/electronic batch records/Veeva
Responsibilities
Initiate and close deviations/CAPAs/Change Controls; Generate and revise SOPs and batch records; Develop short-term manufacturing schedules and assign technicians; Maintain training matrix and coordinate onboarding; Track scheduling adherence and resource utilization metrics; Facilitate communication between supervisors, planners, and stakeholders
Seniority
Mid-level, hands-on IC