Manufacturing Specialist I
Core
Support documentation, lead investigations into nonconformances, manage change controls, and ensure GMP compliance for cell therapy manufacturing.
Role type
Manufacturing Specialist I (Cell Therapy)
Builds
TIL cell therapies for solid tumor patients
Domain
Biopharmaceuticals / Immuno-oncology / Cell Therapy Manufacturing
Required skills
GMP compliance, aseptic processing, root cause analysis, change control management, SOP drafting, data review, cleanroom operations, LIMS/MES familiarity, troubleshooting
Preferred skills
21 CFR Part 11 knowledge, FDA regulations familiarity, team leadership, ambiguity management
Technologies
LIMS, MES, Microsoft Excel, Microsoft Word, Microsoft Outlook
Responsibilities
Draft and approve SOPs and Batch Records, lead investigations into deviations and nonconformances, manage change controls, review data from less experienced staff, troubleshoot moderately complex operational issues, attend weekly management meetings
Seniority
Junior, hands-on IC