Quality Control Lab Analyst II

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The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast‑growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

The QC Analyst II is responsible for performing and supporting a broad range of advanced laboratory functions related to viral vector production and analytics in accordance with cGMP testing guidelines. In this role, the analyst independently executes complex molecular biology assays, aseptic cell culture techniques, and analytical testing with minimal supervision. The position also includes responsibilities for sample and materials management, solution/media preparation, and general lab maintenance, with an increased emphasis on method troubleshooting, data review, and deviation documentation.

The QC Analyst II contributes to method qualification, equipment calibration and validation, and supports continuous improvement efforts. This role serves as a technical resource for junior analysts, helping to uphold quality standards and drive operational excellence within the Quality Control team.

• Independently manage ordering, inventory control, and lifecycle tracking of lab reagents and critical materials to ensure uninterrupted testing operations
• Coordinate and oversee sample organization, prioritization, and testing workflows with minimal supervision
• Lead sample shipping and receiving processes for internal and outsourced testing, ensuring accurate chain of custody and compliance with applicable regulations
• Execute complex hands‑on laboratory procedures related to viral vector production and analytical characterization, including troubleshooting and optimization of methods
• Review and ensure accurate, compliant cGMP documentation of laboratory activities; support deviation investigations and CAPA implementation as needed
• Perform advanced laboratory and equipment maintenance, and coordinate with internal teams or vendors for calibration, qualification, and repair activities
• Serve as a technical trainer and mentor to new staff and junior analysts, supporting their development and adherence to best practices
• Ensure compliance with all established policies, SOPs, and cGMP requirements while identifying opportunities for procedural improvements
• Collaborate with Quality Assurance and leadership in the development, review, and revision of SOPs, protocols, and related documentation
• Responsible for attending client project meetings, tracking related QC activities and ensuring timely execution of project milestones
• Actively support and contribute to method qualification, validation, and transfer activities, including drafting protocols, analyzing data, and preparing summary reports

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field

2+ years of relevant industry experience in QC, R&D, product development, or operations

Excellent computer, verbal, and written communication skills

Experience with laboratory techniques including cell culture, cell‑based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis

While performing the duties of this job, the employee is required to meet the following physical…