Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Core
Leading the design, execution, and interpretation of complex molecular biology analytical programs for cell therapy drug products, including method optimization, transfer, and validation.
Role type
Senior Principal Scientist (Cell Therapy Analytical Science)
Builds
Commercial QC analytical methods and regulatory submissions for viral vector and cell therapy drug products
Domain
Biopharmaceuticals / Cell Therapy / Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Molecular biology methods (lentiviral, AAV vectors), cGMP regulations, method lifecycle management, technical writing, strategic problem solving, team leadership, regulatory inspection representation
Preferred skills
Bioanalytical techniques (cell-based assays, ELISA, flow cytometry), instrument operation standardization, cross-functional collaboration
Technologies
Lentiviral vectors, AAV vectors, cell-based assays, ELISA, flow cytometry
Responsibilities
Lead and manage a team for molecular biology method investigation, optimization, transfer, and validation; Perform hands-on laboratory work for commercial QC method remediation and optimization; Critically evaluate experimental data to identify scientific risks and generate insights; Act as Subject Matter Expert for functional areas; Represent the department in product review boards and regulatory inspections; Author analytical sections of regulatory submissions; Implement method lifecycle maintenance programs; Partner with development organizations on study design and reagent characterization; Hire, mentor, and develop ASAT personnel
Seniority
Principal, hands-on IC with strategic leadership
