Senior MS&T Process Engineer Cell Therapy GMP

astellas; Massachusetts; On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Annual bonus potential

Competitive paid time off

Job summary

Astellas, based in Westborough, MA, seeks a Sr. BioPharma Manufacturing MSAT Process Engineer (Sr. Scientist) to lead GMP-ready manufacturing campaigns for stem cell therapies, drive tech transfer, and advance process robustness.

This senior scientist will design experiments, analyze data, author technical reports, mentor junior staff, and ensure inspections readiness while collaborating across QA, QC, RegCMC, Supply Chain, and Manufacturing.

Qualifications

• BS, MS or PhD in Cell Biology, Stem Cell Biology, Developmental Biology, Bioengineering, Biotechnology, Life Sciences, Pharmaceutical 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.
• Hands-on experience in human cell culture and cell therapy manufacturing support; small-scale and scale-up cell culture systems preferred.
• Experience developing study protocols, executing studies, analyzing data, and writing technical reports to support decision-making.
• GMP manufacturing support experience including deviation investigation, CAPA, change control, and data integrity.
• Ability to analyze data trends, communicate to technical and non-technical stakeholders; cross-functional collaboration experience.

Responsibilities

• Design, author, and execute laboratory study protocols for stem-cell-based processes including culture, differentiation, and scale-up.
• Analyze experimental and manufacturing data; interpret results in context of CPPs, CQAs, and control strategies.
• Author technical reports, study summaries, data packages, and monitoring plans to support GMP readiness and technology transfer.
• Provide MS&T technical support for GMP campaigns, including deviation investigation and CAPA development.
• Lead or contribute to technology transfer and commercial readiness activities; assist with Pre-PPQ/PPQ readiness.
• Assess raw materials and changes; support mitigation with Supply Chain, Quality, and Manufacturing.
• Drive data trending, digital data practices, and opportunities for standardization and automation.
• Represent MS&T in cross-functional forums; mentor junior staff and partner with Manufacturing and PD.
• Support audit/inspection readiness with accurate GMP documentation and data integrity.

Skills

MSAT/MS&T experience

Cell therapy manufacturing

Data analysis

GMP documentation

Technology transfer

Education

BS/MS/PhD in relevant field

Job description

Astellas, based in Westborough, MA, seeks a Sr. BioPharma Manufacturing MSAT Process Engineer (Sr. Scientist) to lead GMP-ready manufacturing campaigns for stem cell therapies, drive tech transfer, and advance process robustness.

This senior scientist will design experiments, analyze data, author technical reports, mentor junior staff, and ensure inspections readiness while collaborating across QA, QC, RegCMC, Supply Chain, and Manufacturing.