MSAT Biotherapeutics Drug Product Senior Manager

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Join us as the MSAT Biotherapeutics Drug Product Senior Manager and help shape the design, start-up, and future operation of a new biologics drug product site spanning fill-finish, device assembly, and secondary packaging. This is an opportunity to serve as a senior technical leader, influence critical manufacturing and validation strategies, build positive relationships, and establish compliant, innovative operations that will support patients for years to come.

Provide technical leadership and subject-matter expertise for sterile manufacturing processes, including compounding, formulation, filling, optical inspection, device assembly, and packaging. Partner with Engineering to define cleanroom layouts, personnel and material lows, equipment placement, and other critical facility design requirements. Lead or support risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify critical process parameters, risks, and appropriate control strategies.

Participate in design reviews and find opportunities to improve process robustness, operational efficiency, and overall effectiveness. Collaborate with Quality Assurance, Global Engineering and Technology (GET), and Operations throughout commissioning, qualification, start-up, and operational readiness.

Own the development and lifecycle management of smoke-study and airflow-visualization strategies. Assess personnel and equipment interventions within critical zones and evaluate unidirectional airflow performance and aseptic process design. Support facility modifications, qualification activities, and operational readiness through airflow and contamination-control assessments. Lead aseptic process simulation (APS) and validation programs for sterile filling operations, including media-fill design, execution, evaluation, and lifecycle management.

Define scientifically justified worst-case conditions and intervention strategies for APS studies. Evaluate APS outcomes, environmental-monitoring data, and contamination-control trends to identify risks and drive continuous improvement. Ensure the ongoing qualification of filling lines, personnel, and aseptic practices. Establish and maintain the site Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1 and other global regulatory expectations. Lead or support investigations and resolution of sterility-assurance events.

Serve as the site subject-matter expert during health authority inspections and regulatory audits. Lead the cleaning-validation lifecycle, including strategy development, scientifically justified acceptance criteria, periodic review, and continued monitoring. Support equipment changes, new product introductions, campaign manufacturing, and risk-based cleaning strategies for biologic and high-potency products, as applicable. Provide technical leadership for sterilization programs, including vaporized hydrogen peroxide (VHP) decontamination, autoclave-cycle development, and sterile-filtration processes.

Evaluate sterilization-cycle changes, maintain the validated state, and support related investigations.

Develop and execute site validation…