Senior MSAT Process Engineer, Cell Therapy Manufacturing

Astellas; Westborough (MA); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

PTO & Holidays

401(k) Match

Bonus Program

Long-Term Incentive

Company Vehicle

Job summary

Astellas is seeking a Senior BioPharma Manufacturing MSAT Process Engineer in Westborough, MA to enable GMP execution, technology transfer, and lifecycle support for MA-TC programs. The role collaborates with Manufacturing, Process Development, Quality, Validation, and Supply Chain to ensure readiness and right-first-time performance.

You will design lab studies, analyze data, write technical reports, support audits, and mentor junior staff while advancing process monitoring and digital data

Qualifications

• BS, MS or PhD in Cell Biology, Stem Cell Biology, Developmental Biology, Bioengineering, Biotechnology, Life Sciences, Engineering, or related discipline with 10+ years for BS, 7+ years for MS, or 3+ years for PhD in cell therapy, regenerative medicine, GMP manufacturing, MS&T, Process Development, Process Engineering, Validation, or related technical operations.
• Strong cell biological background with hands-on experience in human cell culture, cell-based process development, and/or cell therapy manufacturing support; small-scale and scale-up culture systems are preferred.
• Demonstrated experience developing study protocols, executing laboratory studies, analyzing data, and writing technical reports that support process understanding and decision-making.
• Direct GMP manufacturing support experience including deviation investigation, CAPA, change control, batch record review, technical writing, and data integrity expectations.
• Ability to analyze process data, identify trends, and communicate conclusions to technical and non-technical stakeholders.
• Knowledge of technology transfer, process risk assessment, process monitoring, GMP documentation, and inspection readiness in biologics/cell therapy environments.
• Strong problem-solving, organizational discipline, and ability to manage multiple priorities in a fast-paced GMP/lab environment.
• Excellent cross-functional communication and influence skills across Manufacturing, PD, QA, QC, Validation, Supply Chain, Automation/IT, Regulatory/CMC.
• Willingness to mentor junior staff and develop technical training content.

Responsibilities

• Design, author, and execute laboratory study protocols for stem-cell-based processes, including culture, differentiation, and scale-up.
• Analyze experimental and manufacturing data using statistical and digital tools; interpret in the context of CPPs, CQAs, and process risks.
• Write technical reports, study summaries, and data packages to support GMP robustness and technology transfer.
• Provide data-driven MS&T technical support for GMP campaigns, troubleshooting, deviation investigations, CAPA, and change control input.
• Lead or contribute to technology transfer and commercial readiness activities including Pre-PPQ/PPQ readiness and sampling strategies.
• Assess raw materials and single-source materials; collaborate with Supply Chain on mitigation strategies.
• Advance process monitoring and digital data practices to improve visibility and inspection readiness.
• Represent MS&T in cross-functional forums with clear recommendations and action plans.

Skills

Stem cell biology

GMP manufacturing

Data analysis

Technical reporting

Cross-functional collaboration

Process development

Mentoring

Education

BS/MS/PhD in relevant field

Tools

LIMS

ELN

SAP

Excel

Power BI

JMP

Job description

Astellas is seeking a Senior BioPharma Manufacturing MSAT Process Engineer in Westborough, MA to enable GMP execution, technology transfer, and lifecycle support for MA-TC programs. The role collaborates with Manufacturing, Process Development, Quality, Validation, and Supply Chain to ensure readiness and right-first-time performance.

You will design lab studies, analyze data, write technical reports, support audits, and mentor junior staff while advancing process monitoring and digital data