Principal Scientist Analytical Quality Control

Principal Scientist, Analytical, Quality Control

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

The Principal Scientist for QC Analytical plays a key role in supporting QC Analytical operations and activities, ensures compliance and supports GMP manufacturing. The principal scientist will optimize and validate analytical test methods and contribute to commercial readiness initiatives. The principal scientist will lead investigations, implement CAPAs, prepare technical documents, collaborate cross-functionally and function as Analytical SME

Role and Responsibilities

• Ensure data integrity for all QC Analytical laboratory data and support QC equipment validation, maintenance, and calibration.
• Perform routine in-process and release QC testing of AIRM cell products.
• Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports, troubleshooting and optimizing existing methods.
• Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.
• Author, revise and review SOPs, qualification/validation protocols and reports.
• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations, Change Requests and CAPAs related to analytical procedures.
• Assist in the preparation of reports and data packages for interactions between AIRM and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
• Provide SME support for critical manufacturing investigations, including impact assessment, root cause analysis, and corrective/preventive actions.
• Implement commercial readiness initiatives, electronic GMP systems, and support regulatory filings and inspections.
• Evaluate new technologies and business processes for continuous improvement and commercial GMP readiness.