| Job Description: | QC Laboratory Operations & Compliance - Lead day-to-day operations of the QC laboratory in support of in-process, release, and stability testing
for GMP clinical materials. - Author, revise, and implement SOPs, specifications, forms, protocols, reports, and laboratory
documentation to maintain a robust and scalable QC system. - Review and approve laboratory records, test results, logbooks, worksheets, protocols, reports, and other
controlled documentation for completeness, accuracy, and compliance. - Lead or support laboratory investigations related to OOS, OOT, deviations, atypical results, excursions,
and CAPA - Support method qualification, transfer, validation readiness, and new assay implementation as programs
evolve.
Team Leadership & Lab Oversight - Supervise QC staff, including training, scheduling, workload prioritization, performance management, and technical development.
- Support the environmental monitoring program for classified GMP spaces, including scheduling, trend review, documentation, and collaboration with Facilities and QA on excursions and corrective actions.
- Oversee laboratory equipment readiness, maintenance, calibration, qualification, and troubleshooting coordination to ensure an inspection-ready QC operation.
Cross-Functional Collaboration Partner closely with Manufacturing, Facilities, and Quality Assurance to align testing priorities with production schedules, investigations, batch disposition needs, and facility monitoring requirements. |
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| Preferred: | - Working knowledge of cGMP, GLP, GDP, deviation management, investigations, CAPA, change control,
and data integrity principles. - Minimum 5-8 years of relevant experience in a GMP-regulated biopharmaceutical, biotechnology, cell
therapy, gene therapy, or CDMO environment, including progressive QC laboratory responsibilities. - Prior experience supporting cell therapy, gene therapy, immunotherapy, or other advanced therapy
products. - Hands-on experience with cell-based assays, flow cytometry, PCR/qPCR, molecular assays, sterilityrelated
testing support, and/or potency-related assay - Experience with environmental monitoring in classified cleanroom environments.
- Experience with method transfer, qualification, validation support, and assay lifecycle management.
- Prior experience supervising or mentoring laboratory personnel
- Excellent attention to detail and commitment to data integrity; Strong written and verbal communication
skills
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