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.

$96,350-$110,700

Master's degree in an appropriate area and seven years of relevant experience.

• 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

Application must be submitted by 11:55 p.m. (ET) of the posting end date.