Job Description

Senior QC Scientist needed to manage quality control programs and serve as liaison between clients, internal teams, and testing laboratories at an FDA-licensed gene therapy manufacturing facility in Harmans, Maryland. The role coordinates testing activities, maintains timelines, and ensures compliance with GMP and regulatory standards.

Responsibilities

• Serve as primary QC liaison for clients, project teams, and external testing laboratories
• Coordinate QC activities across departments to support GMP manufacturing readiness
• Manage internal and external testing execution, method transfers, and deliverable tracking
• Oversee sample, reagent, and material inventories, shipments, and logistics coordination
• Establish stability programs and develop project trackers monitoring QC milestones and testing progress

Requirements

• Bachelor's degree in Biology, Chemistry, Engineering, Pharmacy, or related field
• 4–8 years of Quality Control experience in regulated environment
• Strong knowledge of GMP regulations, ICH guidelines, and FDA/USP/EP standards
• Proficiency with Microsoft Office Suite, Microsoft Project, and Smartsheet
• Excellent written and verbal communication with cross-functional collaboration skills
• Strong analytical and problem-solving capabilities for complex QC issues
• Demonstrated attention to detail and organizational skills in fast-paced settings

Compensation: $110,000–$120,000 base plus bonus

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