Scientist II Clinical Bioanalysis

Scientist II

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 Astellas.com.

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

This role combines scientific expertise and project management leadership to oversee bioanalytical activities across clinical development programs, serving as a key liaison between internal teams and external laboratory partners. The scientist supports bioanalytical and biomarker assay strategies, including assay development, validation, and implementation, while managing timelines, risks, and regulatory requirements to ensure successful study execution. By generating high-quality bioanalytical and biomarker data, the role supports clinical study endpoints, pharmacodynamic assessments, regulatory submissions, and critical decision-making throughout the drug development lifecycle.

Role and Responsibilities

• Oversee assay development and routine sample preparation, extraction, and analysis using ELISA, PCR, Sequencing, Flow Cytometry, ELISpot, IHC or other platforms.
• Follow validated methods and standard operating procedures with strong attention to detail under the principles of Good Laboratory Practices (GLP) or GCLP-like regulations.
• Serve as the primary contact for CRO bioanalytical activities, including method transfer, troubleshooting, and data review.
• Oversee method validation/qualification activities.
• Collaborate with Astellas team members and CROs to ensure timely completion of study deliverables within timelines and budgets.
• Responsible for clinical bioanalysis related regulatory submission activities.