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3 weeks ago Be among the first 25 applicants Who We Are RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. Our Culture and Values At RoslinCT, our team contributes to revolutionary treatments. We live by core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, Trust, and Respect. We provide a flexible and empowering work environment, attractive benefits, and emphasize work-life balance. Our success relies on our people, and we focus on developing our culture, growth, and patient impact. Position Overview The Quality Control Technical Service (QCTS) Scientist II/Principal supports optimization, qualification, transfer, verification, and QC implementation of methods for cGMP cell therapy products. Responsibilities include collaborating on test methods, writing protocols and reports, overseeing method lifecycle activities, supporting equipment onboarding, and ensuring compliance with quality systems and cGMPs. Key Responsibilities Develop and review qualification, verification, validation protocols, test methods, and reports. Design, develop, and execute procedures supporting method lifecycle activities. Coordinate with external laboratories for contract testing. Support installation and qualification of QC equipment, ensuring 21 CFR Part 11 compliance. Lead investigations, deviations, change controls, and CAPAs. Develop training materials and train new staff as a method SME. Collaborate with cross-functional teams including Analytical Development, QA, and Program Management. Engage with external partners on technical transfer activities. Lead project completion and mentor junior staff. Support cell therapy stability programs through protocol development, data analysis, and reporting. Qualifications Bachelor's degree in a scientific discipline with 12+ years of experience; MS preferred. Experience in a cGMP QC laboratory. Knowledge of method lifecycle guidances (e.g., ICH). Proficiency in statistical applications for analytical methods. Experience with cell-based assays, Flow Cytometry, ELISA, qPCR; rapid microbiological methods a plus. Excellent communication and troubleshooting skills. Ability to work independently in a fast-paced environment, managing multiple priorities. Working Conditions Monday-Friday, 8am-5pm, with flexible shifts including weekends and support for 24/7 operations as needed. Physical Requirements Ability to lift up to 25 pounds, stand for extended periods, and perform repetitive tasks. Our Commitment RoslinCT values diversity and inclusion, fostering a welcoming environment. We are an equal-opportunity employer committed to creating a diverse community where everyone can thrive.

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