Senior MSAT Engineer: Cell Therapy Tech Transfer (Remote)

Aurion Biotech Inc.; United States; On-site; USD 140,000 - 164,000; Full time

Job summary

Aurion Biotech is seeking a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites. This role independently leads complex technical workstreams and collaborates with CDMOs to ensure robust, compliant commercial operations.

The ideal candidate has 7+ years in biologics/cell therapy manufacturing, strong technical writing, and experience with process control strategies, risk assessments, and transfer

Qualifications

• 7+ years of industry experience in MS&T, manufacturing or process development.
• Experience with late-stage clinical, BLA-enabling, or commercial manufacturing.
• Experience with technology transfers for biologics or cell therapies.
• Experience with external manufacturing sites and CDMOs.
• Solid understanding of cGMP and ICH guidelines for biologics or cell therapy.

Responsibilities

• Lead and support technology transfer workstreams for late-stage clinical and commercial manufacturing.
• Assess facility fit, feasibility, process and equipment readiness, and documentation.
• Author protocols, risk assessments, batch records, training materials, and change controls.
• Collaborate with CDMOs to ensure compliant GMP manufacturing and transfer readiness.
• Provide on-site PiP technical support during campaigns; troubleshoot and resolve GMP deviations.
• Identify continuous improvement opportunities and initiate changes through to implementation.

Skills

Technical writing

Cross-functional collaboration

GMP manufacturing

Project ownership

Risk assessments

Data analysis (JMP/Excel)

Education

BS/MS/PhD in scientific or engineering field

Tools

JMP

Excel

Job description

Aurion Biotech is seeking a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites. This role independently leads complex technical workstreams and collaborates with CDMOs to ensure robust, compliant commercial operations.

The ideal candidate has 7+ years in biologics/cell therapy manufacturing, strong technical writing, and experience with process control strategies, risk assessments, and transfer