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

** 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.

** Required Qualifications*
* + 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 and proven ability to work independently, prioritize and manage multiple tasks simultaneously and successfully 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 appropriate relevant regulatory guidance (e.g., ICH, FDA, and EMA)

+ Previous experience supporting a cGMP facility.

+ Prior background in QC Analytical at a biotech/pharma company and experience with preparations and activities associated with site licensure, commercial readiness and experience with Analytical Method Validation required.

+ 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 will be expected to perform other duties and/or special projects, as assigned.

** Preferred Qualifications*
* + 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

** Location and Working Environment*
* + This position is based in Westborough, MA and will require on-site work.

+ This is an on-site role working in a cGMP regulated manufacturing facility.

+ On occasion, this role may travel to other Astellas sites (0-5%)

** What awaits you at Astellas?*
* + Global collaboration:
Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

+ Real-world patient impact:
Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

+ Relentless

Innovation: Join a company at the forefront of…