Quality Scientist II

Job Title: Quality Scientist II Job Description The Quality Scientist II works within the Quality Department to support the testing and analysis of cGMP-produced viral vectors and cells. This role operates in a regulated GMP laboratory environment, performing and developing QC methods, supporting microbiological environmental monitoring, and maintaining high standards of documentation and compliance for cellular and gene therapy products. The position collaborates closely with senior QC staff to help shape and implement strategic direction for the GMP area and contributes directly to the production of phase-appropriate clinical materials. Responsibilities Perform QC laboratory testing on cGMP-produced viral vectors and cells using techniques such as PCR, qPCR, ddPCR, gel electrophoresis, pH measurements, and related molecular biology assays. Support the development, optimization, and qualification of QC methods and assays under the guidance of senior staff. Analyze microbiological environmental monitoring samples and document results in accordance with established procedures. Write, review, and revise Standard Operating Procedures (SOPs) to ensure they accurately reflect current laboratory practices and regulatory expectations. Perform routine equipment maintenance, monitoring, and basic troubleshooting to ensure laboratory instruments remain in a qualified and reliable state. Manage materials and supplies for QC and Production, including tracking inventory, coordinating replenishment, and ensuring appropriate storage and handling. Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the controlled manufacturing facility. Ensure all product samples are accurately labeled and that sample allocation, handling, and transfer are fully documented in the appropriate formats and systems. Maintain full accountability for product samples as they are distributed across different testing requirements and storage conditions. Evaluate processes related to sample management, identify gaps or inefficiencies, and implement improvements to enhance quality and throughput. Complete, review, file, and archive documentation according to SOPs and applicable regulatory requirements. Maintain compliance with regulatory requirements for cellular and gene therapy products through adherence to GMP, data integrity, and documentation standards. Perform daily work in accordance with established policies, procedures, and techniques, applying training and working knowledge to complete assigned tasks. Collaborate effectively in a diverse and team-oriented environment, using clear communication to support high productivity and shared goals. Document all activities performed in accordance with quality and regulatory expectations, ensuring accuracy, completeness, and traceability. Essential Skills Bachelor’s degree (BS) in Biology or another relevant scientific discipline. Prior GMP laboratory experience, including familiarity with regulated documentation and quality systems. Hands-on experience performing molecular biology assays such as PCR, qPCR, and gel electrophoresis. Experience with assay execution and exposure to assay development activities. Strong understanding of regulatory and documentation requirements in a GMP environment, including data integrity and audit readiness. Ability to write, review, and follow SOPs and other controlled documents. Competence with basic laboratory techniques such as dilutions and pH measurements. Ability to work under close supervision while applying training and working knowledge to complete tasks accurately and efficiently. Strong attention to detail and organizational skills for sample management and documentation. Effective communication skills and the ability to work collaboratively within a cross-functional team. Additional Skills & Qualifications Experience working with cellular and gene therapy products or other biologics in a GMP setting. Background in microbiology or environmental monitoring in a regulated facility. Experience contributing to method development or optimization in a QC environment. Familiarity with quality management systems supporting clinical or commercial manufacturing. Ability to identify process gaps in sample or materials management and propose practical improvements. Comfort working in a growing, dynamic organization with opportunities for internal advancement. Work Environment The role is based in a new, state-of-the-art GMP facility with modern laboratories and equipment dedicated t