Senior Scientist – Cell Therapy CMC & Process Development

astellas; Massachusetts; On-site; USD 119,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

401(k) match

Bonus eligibility

Life insurance

Paid time off

Job summary

Astellas is seeking a Senior Scientist to lead formulation, process development, and CMC strategies for cell therapy programs in Westborough, MA. You will drive technology transfer, lifecycle management, and regulatory readiness from IND through commercialization, partnering across Manufacturing, MSAT, Quality, and Regulatory Affairs to deliver robust products.

The ideal candidate has a PhD or MS/BS with extensive biotech/pharma experience, strong communication, and a track record in GMP

Qualifications

• BS/MS/PhD in life sciences with highly relevant biotech/pharma experience.
• Experience in drug product development including formulation development, manufacturing process development, control strategy development and technology transfer.
• Strong understanding of global regulatory expectations and guidelines (FDA, ICH, PIC/S, EU GMP).

Responsibilities

• Lead formulation, process development and CMC strategies for cell therapy drug product development and regulatory submissions from IND through commercialization.
• Design, execute and interpret studies to support process readiness, technology transfer, process validation and regulatory submissions.
• Identify readin ess gaps, assess risks and develop mitigation plans for product development and regulatory readiness.
• Generate scientific rationales, risk assessments, technical reports, and CMC data packages for regulatory submissions and inspections.
• Collaborate with Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain and external partners for technology transfer and lifecycle management.
• Author, review and approve technical documents, protocols, reports and submission content.
• Drive continuous improvement to enhance product quality, process robustness and manufacturability.
• Provide technical leadership and mentorship to junior scientists and project teams.

Skills

Cross-functional leadership

Verbal & written communication

Regulatory submissions

Biotech/pharma knowledge

Education

Bachelor/Master/PhD in life science

Job description

Astellas is seeking a Senior Scientist to lead formulation, process development, and CMC strategies for cell therapy programs in Westborough, MA. You will drive technology transfer, lifecycle management, and regulatory readiness from IND through commercialization, partnering across Manufacturing, MSAT, Quality, and Regulatory Affairs to deliver robust products.

The ideal candidate has a PhD or MS/BS with extensive biotech/pharma experience, strong communication, and a track record in GMP