Senior Scientist, Cell Therapy CMC & Regulatory Lead

Astellas Pharma; Westborough (MA); On-site; USD 119,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Match

Paid Time Off

Job summary

Astellas Pharma in Westborough, MA is seeking a Senior Scientist to lead drug product readiness activities for cell therapy programs, developing formulations, manufacturing processes, and control strategies to support development, regulatory submissions, and manufacturing readiness.

You will plan and execute development studies, enable commercialization through evidence and technical justifications, and provide technical leadership and mentorship to junior scientists and project teams.

Qualifications

• BS/MS or Ph.D in a life science; BS with 12+ years, MS with 8+ years or Ph.D with 5+ years of highly relevant experience in biotechnology or pharmaceuticals industry.
• Broad knowledge of cell therapy and/or biologics product development and pharmaceutical sciences, and GMP manufacturing principles.
• Experience in drug product development, including formulation development, manufacturing process development, control strategy development and technology transfer
• Experience supporting regulatory submissions, including preparation of CMC documentation and scientific data packages for IND/CTA and BLA/NDA or equivalent submissions.
• Demonstrated ability to identify development challenges, assess product and process risks, and develop data-driven mitigation strategies.
• Strong understanding of global regulatory expectations and guidelines applicable to biologics and cell therapy products, including FDA, ICH, PIC/S, and EU GMP.
• Experience supporting GMP manufacturing operations, including aseptic processing and sterile drug product manufacturing
• Excellent verbal and written communication skills, with the ability to effectively lead and influence cross-functional teams.

Responsibilities

• Lead formulation, process development, process characterization activities and CMC strategies as part of a multi-team structure supporting cell therapy drug product development and regulatory submissions from IND through commercialization.
• Design, execute, and interpret studies required to support process readiness, technology transfer, process validation, regulatory submissions, and lifecycle management.
• Identify product, process, and CMC readiness gaps; assess risks and develop mitigation plans to support product development and regulatory readiness.
• Generate scientific rationales, risk assessments, technical reports, and CMC data packages to support regulatory submissions, agency interactions, and regulatory inspections.
• Partner with Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, and external organizations to ensure successful technology transfer and lifecycle management.
• Author, review, and approve technical documents, protocols, reports, and regulatory submission content.
• Drive continuous improvement initiatives to enhance product quality, process robustness, manufacturability, and operational efficiency.
• Provide technical leadership and mentorship to junior scientists, research associates and project teams.

Job description

Astellas Pharma in Westborough, MA is seeking a Senior Scientist to lead drug product readiness activities for cell therapy programs, developing formulations, manufacturing processes, and control strategies to support development, regulatory submissions, and manufacturing readiness.

You will plan and execute development studies, enable commercialization through evidence and technical justifications, and provide technical leadership and mentorship to junior scientists and project teams.