Teams at Kincell Bio

Provides technical leadership and hands-on oversight of QC microbiology and environmental monitoring in GMP manufacturing environments. Supervises testing, investigations, contamination control, data trending, external laboratory coordination, equipment qualification, method validation, documentation review, personnel training, and inspection readiness. Collaborates cross-functionally with Quality Assurance, Manufacturing, Engineering, and Validation teams while ensuring compliance with GMP, aseptic practices, data integrity, and regulatory requirements.

Supports day-to-day Quality Assurance activities for GMP cell and gene therapy manufacturing. Responsibilities include material and product release, QMS documentation, SOPs, batch record and validation review, quality event investigations, GMP/GDP compliance, and continuous improvement. The role collaborates with Manufacturing, Quality Control, Supply Chain, Facilities, and Laboratories in a site-based cleanroom environment.

Supports cell therapy process development operations under senior supervision, prepares meeting materials, drafts and reviews technical documents, maintains laboratory areas and materials, and supports 5S and Kanban systems. The role contributes to continuous improvement, quality-focused development practices, and operational effectiveness. This is a three-month, site-based contract in Gainesville, Florida, with occasional early morning or late evening hours and no travel.