Sr. BioPharma Manufacturing MSAT Process Engineer (Sr. Scientist) at Astellas

Department: Astellas Institute for Regenerative Medicine

Compensation

$105,280 – $150,400/yr

Location: Westborough, Massachusetts
Type: Full-time
Level: senior
Posted: Aug 20, 2026

Summary from listing

Astellas is hiring a Senior BioPharma Manufacturing MSAT Process Engineer (Sr. Scientist) to provide technical leadership for human stem-cell-based cell therapy manufacturing, including GMP execution, technology transfer, commercial readiness, process control, data analysis, troubleshooting, regulatory and CMC support, and audit readiness. The role is based in Westborough, Massachusetts, requires on-site work in a cGMP laboratory and manufacturing environment, and offers a salary range of $105,280 to $150,400 with medical, dental, and vision insurance.

Required Skills

Cell culture
GMP manufacturing
Technology transfer
Process control
Statistical analysis
Data integrity
Root cause analysis
JMP

Additional Information

Minimum Education: Bachelor's, master's, or PhD in Cell Biology, Stem Cell Biology, Developmental Biology, Bioengineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Engineering, or a related discipline
Required Previous Experiences: 10+ years of relevant experience for a BS, 7+ years for an MS, or 3+ years for a PhD in cell therapy, regenerative medicine, GMP manufacturing, MS&T, Process Development, Process Engineering, Validation, or related technical operations
Hands-on experience in human cell culture, cell-based process development, and/or cell therapy manufacturing support
Direct GMP manufacturing support experience, including deviation investigation, CAPA, change control, batch record review, technical writing, and data integrity
Working knowledge of technology transfer, process risk assessment, process monitoring, GMP documentation, and phase-appropriate technical readiness in complex aseptic manufacturing environments
Preferred Qualifications: Experience with both small-scale and scale-up cell culture systems
Direct experience with regenerative medicine platforms, aseptic cell processing, or complex biologics manufacturing
Experience supporting late-stage clinical or commercial readiness, including Pre-PPQ, PPQ, process validation, continued process verification, process control strategy, or Regulatory/CMC support
Experience designing and executing laboratory studies bridging Process Development, MS&T, and GMP Manufacturing needs
Experience with statistical tools and digital/data systems such as JMP, Excel, Power BI, EBR, LIMS, ELN, or SAP
Familiarity with ICH Q8–Q12, process validation, Quality by Design, control strategy, and inspection readiness
Success leading technical workstreams, building laboratory or digital capabilities, standardizing workflows, and improving operational discipline