Senior Quality Control Analyst

Company Our client is a leader in advancing immunotherapy and engineered T cell therapies. They are on the cutting edge of revolutionizing cancer treatment by developing personalized, innovative therapies. The company fosters a dynamic and fast-paced environment where scientific discoveries are made daily, encouraging continuous growth and development within their teams.

Job Description As a Senior QC Analyst you will join the Quality Control (QC) department. In this role, you will oversee the validation and implementation of new analytical methods, support their ongoing QC laboratory activities, and contribute to the continuous improvement of processes related to cell therapy products. Your expertise will help ensure the quality and compliance of the manufacturing processes and product testing.

Responsibilities Collaborate with global teams to coordinate and facilitate new method and technology introductions within the QC department. Lead projects for the transfer and validation of new analytical methods and instruments, ensuring smooth implementation. Author, review, and revise analytical method protocols, validation documents, and related technical reports. Support troubleshooting activities for analytical assays and oversee CAPA (Corrective and Preventive Actions) when necessary. Participate in investigations of Out-Of-Specification (OOS) results and manage deviations related to analytical procedures. Monitor and trend analytical and stability data to identify issues and opportunities for process improvements. Interface with contract manufacturing organizations to resolve QC testing issues. Maintain compliance with cGMP regulations by reviewing and updating documents, procedures, and systems. Lead or support process improvements, including GMP system monitoring and audit readiness.

Requirements Master’s degree in Chemistry or Biology with 8+ years of relevant industry experience, or PhD in the same fields with 5+ years of experience. Extensive knowledge of analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays. Solid understanding of cGMP and GLP regulations. Strong project management and collaboration skills. Excellent communication and documentation skills. Proficiency in Microsoft Office, especially Excel and JMP. Ability to work independently and effectively as part of a multidisciplinary team.

Other Information Apply to our vacancy for more information. Looking forward to getting in touch!