Role Summary

The MSAT Associate plays a key role in supporting manufacturing operations, process improvements, and technical troubleshooting for Autolus’ cell therapy products. This position provides hands-on support in technology transfer, process validation, and continuous improvement initiatives to ensure the robustness and scalability of manufacturing processes. The MSAT Associate collaborates closely with cross-functional teams, including Manufacturing, Quality, Process Development, and others, to maintain compliance with GMP standards and drive operational excellence.

Key Responsibilities

• Input, manage and analyze process performance data to identify trends and optimize manufacturing operations.
• Provide technical support to GMP manufacturing operations (including shopfloor presence), troubleshooting process-related issues and driving continuous improvement initiatives.
• Ensure up to date with relevant and required training applicable to job role.
• Work along side manufacturing schedule
• Support technology transfer activities, including the transfer of processes from development to GMP manufacturing and between sites.
• Assist in the execution of process validation, including data analysis and documentation.
• Participate in process risk assessments and implement mitigation strategies to enhance process robustness.
• Collaborate with Process Development to assess process scalability and define critical process parameters.
• Author, review, and revise technical documents, including standard operating procedures (SOPs), batch records, protocols, and reports.
• Support investigations, out-of-specification/trend (OOX), root cause analysis for deviations and non-conformances and contribution towards corrective/ preventive actions (CAPAs).
• Assist in the evaluation and implementation of new technologies to enhance manufacturing efficiency and product quality.
• Maintain compliance with GMP regulations, company policies, and industry best practices.
• Author/ review/ approve raw material specifications used within commercial manufacture

Demonstrated skills and competencies

• Bachelor’s or Master’s degree in Biotechnology, Biochemical Engineering, Life Sciences, or a related field.
• Experience in a GMP-regulated biopharmaceutical or cell therapy manufacturing environment is preferred.
• Knowledge of cell therapy manufacturing processes, including aseptic techniques, bioreactors, and cryopreservation, is a plus.
• Strong analytical and problem-solving skills with the ability to interpret complex data sets.
• Excellent communication and collaboration skills to work effectively in a cross-functional team.
• Ability to work in a fast-paced, dynamic environment with attention to detail and adherence to deadlines.
• Familiarity with regulatory requirements, including MHRA, FDA, and EU GMP guidelines, is desirable.