Lead Process Scientist, Gene Editing Materials (CDMO)

Allogene Therapeutics; South San Francisco (CA); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health insurance

Paid time off

Holiday shutdowns

Job summary

Allogene Therapeutics, based in South San Francisco, seeks a technical lead for Process and Product Development to guide CDMOs in development of gene editing and gene delivery materials for AlloCAR T products. You will support lifecycle activities from early development to PPQ planning and commercial readiness, with cross-functional collaboration across MSAT, Quality, and Manufacturing.

The position requires a PhD/ MS/ BS with extensive GMP experience in gene editing or gene delivery, and the

Qualifications

• PhD/MS/BS with substantial experience in gene editing or gene delivery related field.
• Experience developing GMP manufacturing processes for gene editing materials or gene delivery materials.
• Knowledge of Design of Experiments, statistical analysis, and data visualization tools.

Responsibilities

• Serve as technical SME supporting CDMOs for process and assay development of gene editing and/or gene delivery materials
• Partner with R&D, External Manufacturing, MSAT and Quality for cross-functional alignment
• Develop process development, characterization, control strategy, and PPQ plans
• Assess impact of changes to processes/methods for gene editing/delivery materials
• Plan, execute and troubleshoot deviations of PD and GMP runs at CDMOs
• Design experiments to evaluate impact on CART production process
• Develop analytical assays for gene editing and/or gene delivery materials
• Collaborate with the broader PD team to achieve department goals

Skills

DOE

Statistical analysis

Data visualization

Cross-functional collaboration

Travel readiness

Strong communication

Education

PhD in biological sciences, engineering or related discipline

MS in biological sciences, engineering or related discipline

BS in biological sciences, engineering or related discipline

Tools

JMP

Spotfire

Job description

Allogene Therapeutics, based in South San Francisco, seeks a technical lead for Process and Product Development to guide CDMOs in development of gene editing and gene delivery materials for AlloCAR T products. You will support lifecycle activities from early development to PPQ planning and commercial readiness, with cross-functional collaboration across MSAT, Quality, and Manufacturing.

The position requires a PhD/ MS/ BS with extensive GMP experience in gene editing or gene delivery, and the