Principal Scientist, Analytical, Quality Control

Overview

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 are seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and are not afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

The Principal Scientist for QC Analytical plays a key role in supporting QC Analytical operations, ensuring compliance and supporting 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.

• 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.

• PhD, MS or BS in Cell Biology or equivalent.
• PhD with 6+ years, MS with 8+ years or BS with 10+ years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry.
• Strong experience in developing, optimizing, qualifying and validating Analytical Cell based Assays.
• Demonstrated leadership, critical thinking skills, and the ability to influence and drive milestones; proven ability to work independently, prioritize and manage multiple tasks in a matrix environment.
• Clear and succinct verbal and written communication skills along with strong analytical, problem-solving, critical thinking skills, and excellent organizational skills, with a demonstrated ability to work in a fast-paced environment with changing priorities while maintaining attention to detail.
• Working knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA).
• Previous experience supporting a cGMP facility.
• Prior background in QC Analytical at a biotech/pharma company and experience with site licensure, commercial readiness and Analytical Method Validation.
• Will support and demonstrate quality standards to ensure data of highest quality and will work closely with team and other functional key stakeholders to execute work, and may perform other duties and/or special projects as assigned.

• Advanced degree desirable.
• Experience with LIMS implementation and maintenance.
• Ability/Flexibility to work weekends is required.
• Excellent knowledge of GMP, ICH, USP, EU, JP and global compendial regulations and guidance.

• This position is based in Westborough, MA and will require on-site work.
• This is an…