Senior Principal Scientist, Drug Product Analytical Science and Technology; ASAT), Cell Therapy

Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy

Req Number: R1602888
• Updated:  
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Location:

Seattle, 400 Dexter-WA

This technical leadership role is a highly experienced subject matter expert in molecular biology analytical methods and related areas. The incumbent will lead the design, execution, and interpretation of complex, high-impact scientific programs, managing a team responsible for method optimization, transfer, and validation for the Cell Therapy analytical portfolio. The role balances deep hands‑on laboratory engagement with cross‑functional leadership, mentoring, and enterprise-level impact.

• Lead and manage a team responsible for molecular biology method technical investigation, method optimization/remediation, method transfer, and method validation in compliance with regulatory requirements.
• Perform or direct team hands‑on laboratory work in support of commercial QC analytical methods investigation, remediation, and optimization.
• Critically evaluate experimental data across the team, identifying scientific risks and opportunities, and recommending course corrections.
• Act as a subject matter expert (SME) as needed.
• Make high‑impact scientific and strategic decisions under uncertainty, balancing ambition with pragmatic risk management.
• Represent the department in product review boards and regulatory inspections (internal and external audits). Own and author relevant analytical sections of regulatory submissions and responses to health‑authority questions.
• Implement method lifecycle and maintenance programs to support viral vector and cell therapy drug products.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent ASAT interests on cross‑functional and cross‑site teams and communicate effectively.
• Apply technical knowledge, regulatory requirements, and scientific principles to troubleshoot and solve complex non‑routine issues.
• Hire, mentor, and develop exceptional ASAT personnel.

The position reports to Analytical Science and Technology management.

• Strong scientific background with expertise in molecular methodologies related to lentiviral, AAV vectors, and other gene delivery platforms.
• Advanced technical writing and formal report creation skills.
• Strategic thinking and problem‑solving ability, logically evaluating complex scientific problems.
• Independent work in a fast‑paced matrix environment, meeting deadlines and prioritizing multiple projects.
• Excellent communication and collaboration with peers, senior management, and cross‑functional teams globally.
• Advanced technical skills in execution and interpretation of complex, multi‑dimensional scientific data for commercial QC analytics.
• Experience writing formal reports and technical presentations for investigations and regulatory submissions.
• Biopharmaceutical industry experience with a track record of scientific leadership, innovation, and impact.
• Mentoring, coaching, influencing, negotiating, and personnel interaction skills.
• Willingness to travel to support projects as needed.

• Bachelor's/Master's degree preferably in (bioanalytical) science; advanced degree preferred.
• 10+ years of relevant experience in regulated cellular therapy or gene therapy, or an equivalent combination.
• Expert scientific knowledge in a broad range of molecular techniques, including lentiviral and AAV vectors, and experience with bioanalytical techniques such as cell‑based assays, ELISA, and flow cytometry.
• Deep expertise in characterization, validation, and transfer of bioanalytical method life cycles, including training in method execution, instrument operation, and standardization.
• Experience in cGMP regulations and application within the Quality Control environment; understanding of FDA, EMA, ICH, USP, and EP guidelines for viral vectors, cell therapies, and related products.

Seattle – WA: $152,820 – $185,184 (starting…