MSAT Engineer

Job Responsibilities

• Act as a technical lead for process development and technology transfer activities supporting clinical and commercial manufacturing.
• Design, plan, and manage studies related to process optimization, scale-up, and validation to ensure robust and efficient manufacturing processes.
• Evaluate process robustness through data-driven studies, establishing critical parameters and validation baselines.
• Perform data analysis to identify key process variables impacting product quality and consistency.
• Serve as a subject matter expert (SME) for the Technical Transfer team, representing the group in cross-functional and client-facing meetings.
• Partner with analytical, quality, production, and project management teams to deliver successful project outcomes on time and within scope.
• Prepare and review technical documentation, including protocols, reports, and risk assessments related to validation and technology transfer.
• Support fill-finish manufacturing operations by assisting with deviations, root cause analyses, and implementation of process improvements.
• Ensure all work complies with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines (FDA, EU, ISO).

Qualifications

• B.S. in Science or Engineering with at least 7 years of relevant industry experience; advanced degree preferred.
• Strong leadership, accountability, and decision-making skills, with the ability to perform effectively under pressure and tight timelines.
• Deep understanding of process design, development, scale-up, and optimization for drug product manufacturing, including sterile and aseptic processes.
• Proficient in data evaluation, statistical analysis, and process controls, with the ability to interpret complex results and identify corrective actions.
• Excellent communication, organization, and multitasking abilities, with a proven record of managing multiple priorities in a dynamic environment.
• Thorough knowledge of cGMP standards; familiarity with regulatory frameworks in pharmaceutical development or research is a plus.