Senior MSAT Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

The Senior MSAT Specialist/Engineer is responsible for providing technical leadership across the lifecycle of biologics and advanced therapy products, ensuring robust, compliant, and scalable manufacturing processes. This role serves as a critical bridge between Process Development, Manufacturing, Quality, and external partners to enable successful technology transfer, process validation, and sustained commercial manufacturing. The Senior MSAT Engineer applies deep process and product knowledge to proactively identify risks, drive process improvements, and support regulatory expectations while ensuring reliable supply.

This role is based in Sanford, NC.

• Support and execute technology transfer of upstream, downstream, and/or drug product processes from development into GMP manufacturing, including internal sites and CMOs.
• Own process knowledge throughout the product lifecycle, from early clinical phases through PPQ and commercial operations.
• Provide on-the-floor technical support for GMP manufacturing campaigns, including deviation investigation, root cause analysis, and CAPA development.
• Serve as a subject matter expert for critical process parameters (CPPs), critical quality attributes (CQAs), and process controls.
• Support change management activities, including impact assessments and implementation strategies.
• Lead or support PPQ strategy development, execution, and reporting.
• Support CPV programs through data trending, statistical analysis, and process performance evaluation.
• Ensure validation and lifecycle activities align with regulatory expectations (e.g., FDA, EMA, ICH).
• Identify and implement process improvements to enhance robustness, yield, cost, and manufacturability.
• Apply risk-based tools (e.g., FMEA, QRM per ICH Q9) to assess and mitigate process risks.
• Support introduction of new technologies, platforms, or manufacturing capabilities.
• Contribute to regulatory submissions and respond to health authority questions.
• Act as a technical SME during regulatory inspections and audits.
• Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements.
• Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports.
• Mentor junior MSAT engineers and provide technical guidance across teams.
• Collaborate closely with Process Development, Manufacturing, Automation, Validation, CMC teams, Quality, Supply Chain, and Regulatory Affairs.

Required:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related scientific discipline required
• 6–10+ years of experience in biopharmaceutical manufacturing, process development, MSAT, or technical operations with BS, 4-8+ years with MS, 2-6+ years with PhD
• Direct experience supporting GMP manufacturing for clinical and/or commercial biologics
• Hands‑on experience with technology transfer from development into GMP manufacturing
• Strong understanding of biologics manufacturing processes with expertise in upstream and/or downstream unit operations and ability to support other areas as needed
• Demonstrated experience with process characterization and control strategies, critical quality attributes (CQAs), and critical process parameters (CPPs), deviation investigations, root cause analysis, and CAPA development
• Experience supporting process validation (PPQ) and continued process verification (CPV)
• Solid working knowledge of cGMPs, FDA and EMA expectations, and applicable ICH guidelines
• Experience contributing to regulatory submissions and supporting regulatory…