Scientist II, Analytical Development, Gene Editing and Molecular Assays

Scientist II, Analytical Development, Gene Editing and Molecular Assays

This position will be responsible for developing analytical methods and performing QC and in process sample testing to support the manufacture and characterization of Legend's gene and cellular therapy pipeline and first-in-human/new IND products. The individual will be responsible for analytical methods development, qualification and internal or external transfer; routine testing of final product (GMP), stability, and in-process samples; and performing data review and verification, lab and instrument maintenance etc.

The position will be responsible for maintaining accurate and contemporaneous records in a lab notebook and reporting results in a timely manner.

Key Responsibilities

• Develop, optimize and qualify molecular biology methods for parameters such as: VCN, gene editing proficiency, infectious titer, genomic titer, rapid mycoplasma, surrogate RCL, residual DNA, etc.
• Subject matter expert supporting routine testing of final product (GMP), stability, and in-process.
• Perform review of testing data (e.g., data packets, final lot file, COA review).
• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
• Cross trained in multiple complex analytical methods and/or multiple products.
• Train others on multiple QC test methods, processes and procedures.
• Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
• Maintain accurate and updated lab notebooks.
• Manage equipment and records for maintenance, calibration and operation. Contribute to maintenance of laboratory inventories.
• Procure and qualify required materials to perform experiments or testing.
• Work collaboratively with members of Analytical Development team to establish the analytical control strategy of the established methods.
• Perform other tasks as assigned.
• Typically, you have the authority to make decisions related to planning and execution of assay development runs. You can also make decisions related to weekly work priority. Higher-level approvals are required for those related to significant assay development methodology change, strategic shifts, or collaborations with other functional teams.

Requirements

• BS, MS or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field.
• A BS with 6-8 years of significant practical experience; a MS with 4-6 years of hands-on experience in QC testing and method development and qualification of gene and cell therapy products, Vaccine, Antibody, AAV, other Biologics; or a Ph.D. with 1-3 years of assay development experience in pharmaceutical field.
• Demonstrated experience in assay development and GMP QC testing of Biologicals (e.g., qPCR, dPCR, ddPCR, ELISA, Cell culture and Cell based assays).
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced knowledge of LIMS, ELN, Veeva, Graph Pad Prism, JMP and laboratory data analysis systems preferred.
• Expertise in analytical method qualification and validation, and tech transfer in In Vivo CAR-T, Vaccine, Antibody, AAV, or other Biologics is plus.
• Strong communication skills, both written and verbal, with a demonstrated capacity to thrive in collaborative, team-driven environments.
• Excel, Word, PowerPoint, etc
• Graph Pad Prism, other data analysis tools (PowerBI, JMP, etc)
• ELN, Lab Vantage, etc
• Mandarin preferred.