Principal Scientist, Analytical, Quality Control

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%)