Senior BioPharma Manufacturing MSAT Process Engineer MA-TC

Senior BioPharma Manufacturing MSAT Process Engineer MA-TC

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

Senior Process Engineer, Manufacturing Science & Technology (MS&T) is an experienced technical individual contributor responsible for enabling robust GMP execution, technology transfer, commercial readiness, and lifecycle support for current and future MA-TC manufacturing programs. This role provides data-driven technical leadership across GMP operations, Pre-PPQ and PPQ readiness, process control strategy, material and supply risk assessment, digital/data enablement, and technical capability building. The position works independently and collaboratively with Manufacturing, Process Development, Quality, Validation, QC, Supply Chain, Automation/IT, Regulatory/CMC, and external partners to ensure phase-appropriate process readiness, right-first-time execution, and inspection readiness.

Role and Responsibilities

• Design, author, and execute laboratory study protocols for human stem-cell-based cell therapy processes, including stem cell culture, differentiation, process characterization, process optimization and/or scale-up, new process/technology evaluation, and troubleshooting studies.
• Analyze experimental, process, and manufacturing data using appropriate statistical and digital/data tools; interpret results in the context of cell biology, process understanding, CPPs, CQAs, IPCs, raw material attributes, process risks, and control mechanisms.
• Author clear, scientifically sound technical reports, study summaries, data packages, technical assessments, comparability assessments, process monitoring plans, and recommendations to support GMP robustness, technology transfer, commercial readiness, and future PPQ readiness.
• Provide timely, data-driven MS&T technical support for GMP manufacturing campaigns, including shop-floor technical readiness, troubleshooting, deviation investigation, root cause analysis, CAPA development, change control input, and campaign summary or technical reports.
• Lead or significantly contribute to technology transfer and commercial readiness activities, including process fit assessment, facility fit, process description, batch record readiness, engineering and characterization study planning, Pre-PPQ readiness, PPQ protocol input, sampling strategy, acceptance criteria, and execution support.
• Assess critical raw materials, single-source materials, plastics, consumables, and process-impacting material changes; support mitigation strategies in collaboration with Supply Chain, Quality, Manufacturing, and Process Development.
• Drive process monitoring, data trending, statistical analysis, and fit-for-purpose digital/data practices to improve process visibility, support continued process verification concepts, enable inspection readiness, and identify opportunities for standardization, automation, productivity improvement, and COGM reduction.
• Represent MS&T in cross-functional forums and technical discussions; translate technical information into clear recommendations, decision points, and action plans for stakeholders at different technical levels.
• Support audit and inspection readiness by ensuring technical rationale, GMP documentation, data integrity, process history, and knowledge management records are accurate, retrievable, and scientifically sound.
• Mentor junior MS&T staff and Manufacturing partners by developing structured technical training, sharing process knowledge, strengthening GMP awareness, and supporting sustainable site technical capability.
• Proactively identify gaps in process robustness, GMP execution, laboratory study capability, digital capability, and commercial readiness; propose pragmatic, phase-appropriate improvements aligned with MA-TC strategic priorities and approved CMC timelines.
• Perform other duties and responsibilities as assigned. Responsibilities may evolve based on business needs, organizational priorities, and program requirements.