Senior MSAT Engineer
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
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.
Role and Responsibilities
- 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.