Senior MSAT Engineer Cell Therapy Process Transfer

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Beautiful facility

Collaborative culture

Comprehensive benefits

Job summary

Artiva Biotherapeutics Inc. is seeking a Sr. Manager, MSAT Engineer to lead tech transfer, validation and investigations for complex NK cell manufacturing. You will write MBRs and SOPs, drive deviation handling and CAPA, and monitor processes to ensure GMP compliance.

You will collaborate across QA, manufacturing and biostatistics to develop Track and Trend programs, characterize materials, and support ongoing process improvements in a fast-paced, regulated environment.

Qualifications

• Bachelor’s, Master’s or PhD in biotechnology, chemical engineering or related disciplines.
• Technical depth & process expertise in late-stage clinical and commercial manufacturing.
• Ability to establish business processes, drive standardization and governance in complex environments.
• Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy.
• Cell culture, cell therapy or aseptic processing experience.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records, SOPs, deviation reports and technical risk assessments with a strong understanding of equipment, process and testing.
• Lead deviations process under QA supervision and performs thorough Root Cause Analysis.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Author manufacturing investigations and drives CAPA implementation.
• Support raw materials characterization and E&L risk assessment.
• Creates dashboard to visualize manufacturing data.
• Establish Track and Trend program in collaboration with biostatistics.
• Other duties as assigned.

Skills

Project management

cGMP manufacturing

Process validation

Root cause analysis

Deviation investigations

Quality systems

Cross-functional collaboration

Documentation (MBR/SOPs)

Cell culture / cell therapy

Regulatory compliance

Education

Biotech / Chemical Eng PhD/Master/Bachelors

Job description

Artiva Biotherapeutics Inc. is seeking a Sr. Manager, MSAT Engineer to lead tech transfer, validation and investigations for complex NK cell manufacturing. You will write MBRs and SOPs, drive deviation handling and CAPA, and monitor processes to ensure GMP compliance.

You will collaborate across QA, manufacturing and biostatistics to develop Track and Trend programs, characterize materials, and support ongoing process improvements in a fast-paced, regulated environment.