Senior Scientist, QC Analytical

Senior Scientist, QC Analytical supporting GMP manufacturing of gene therapies and viral vector-based products at a state-of-the-art facility in Harmans, Maryland. The role involves performing analytical assays, troubleshooting laboratory issues, mentoring staff, and ensuring compliance with quality and regulatory standards.

Responsibilities

• Perform analytical and molecular biology assays including ELISA, qPCR, ddPCR, HPLC, and capillary electrophoresis
• Troubleshoot laboratory instrumentation issues and recommend solutions for batch release and stability testing
• Serve as subject matter expert, providing technical guidance to auditors, vendors, and cross-functional teams
• Mentor laboratory staff, train on techniques, and promote adherence to quality standards
• Create and maintain technical documentation including protocols, SOPs, and GMP-controlled records; review and approve data packages

Requirements

• Bachelor's in Life Sciences with 4–6 years cGMP QC lab experience, or Master's with 2+ years cGMP QC experience
• Expertise in QC analytical methods for protein chemistry and molecular biology
• Hands-on biologic, pharmaceutical, or medical device QC experience with strong GMP familiarity
• Experience writing Standard Operating Procedures and biochemistry documentation
• Proficiency with Microsoft Excel and Word; strong attention to detail
• Experience with ELISA, qPCR, ddPCR, HPLC, or capillary electrophoresis (preferred)

Compensation: $50.48–$57.69 per hour plus bonus