Senior Scientist (Drug Product Formulations

Position: Senior Scientist (Drug Product Formulations)
** Senior Scientist*
* ** About Astellas*
* Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at

** Are you driven to make a real difference in the lives of patients?*
* We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

** Purpose & Scope*
* Lead and manage drug product readiness activities for cell therapy programs through the development and optimization of formulations, manufacturing processes, and control strategies to support product development, regulatory submissions, and manufacturing readiness.

Plan, evaluate, and execute development studies required to support process readiness, technology transfer, process validation, and regulatory submissions across all stages of cell therapy product development.

Enable successful commercialization of cell therapy products through the generation of scientific evidence and technical justifications to support regulatory filings and successful advancement of cell therapy programs.

** Role and 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.

** Required 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.

** Preferred Qualifications*
* + Experience supporting development of cell therapy drug products across multiple stages of development.

+ Experience developing product and process understanding through formulation…