Senior Biopharma MS&T Process Engineer - GMP Manufacturing

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

Benefits offered by this job

Medical, Dental and Vision Insurance

401(k) match and company contribution

Annual corporate bonus

Job summary

Astellas is seeking a Senior Process Engineer in Massachusetts to enable robust GMP execution, technology transfer, and lifecycle support for cell therapy manufacturing programs. You will work across multiple functions to ensure phase-appropriate readiness and right-first-time execution.

The role emphasizes data-driven leadership, process monitoring, and collaboration with QA, QC, Regulatory, and Supply Chain teams.

Qualifications

• BS, MS or PhD in Cell Biology, Stem Cell Biology, Developmental Biology, Bioengineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Engineering, or related field with 10+ years for BS, 7+ years for MS, or 3+ years for PhD in cell therapy or related fields.
• Hands-on experience with human cell culture and cell therapy manufacturing support; experience with scale-up systems is preferred.
• Experience designing study protocols, executing lab studies, analyzing data, and writing technical reports to support decision-making.
• Direct GMP manufacturing support including deviation investigation, CAPA, change control, and data integrity expectations.
• Ability to analyze data, identify trends, and communicate conclusions to technical and non-technical stakeholders.

Responsibilities

• Lead or contribute to laboratory studies for stem cell-based processes (culture, differentiation, scale-up).
• Analyze experimental and process data; interpret results for GMP readiness and process understanding.
• Produce clear technical reports, study summaries, and recommendations for BBP readiness.
• Provide MS&T support for GMP campaigns, deviations, and root-cause analysis.
• Mentor junior staff and develop training materials for GMP knowledge.

Skills

Cell culture

GMP operations

Data analysis

Cross-functional collaboration

Mentoring

Education

BS/MS/PhD in related field

Tools

LIMS

ELN

SAP

Power BI

Job description

Astellas is seeking a Senior Process Engineer in Massachusetts to enable robust GMP execution, technology transfer, and lifecycle support for cell therapy manufacturing programs. You will work across multiple functions to ensure phase-appropriate readiness and right-first-time execution.

The role emphasizes data-driven leadership, process monitoring, and collaboration with QA, QC, Regulatory, and Supply Chain teams.