Senior MSAT Engineer – Remote Tech Transfer Leader

Aurion Biotech; United States; Remote; USD 157,000 - 174,000; Full time

Benefits offered by this job

Full health insurance

401(k) matching

Employee assistance program (EAP)

FSA

Generous PTO

Paid parking

Subsidized commuter passes

In-office catered lunches

Job summary

Aurion Biotech is seeking a Principal Engineer, MSAT to lead technology transfer, comparability, and readiness of late-stage and commercial cell therapy products across GMP manufacturing sites. This individual contributor will drive complex workstreams, supervise technical documentation, and partner with sites to sustain robust, compliant processes.

The role requires 10+ years post-degree experience in MSAT or related functions, strong GMP knowledge, and the ability to work across

Qualifications

• BS/MS/PhD in a scientific or engineering discipline.
• 10+ years with a BS; 7+ years with an MS; 5+ years with a PhD in relevant industry.
• Experience in MSAT, manufacturing or process development for biologics/cell therapies.
• Demonstrated commercial-stage comparability and tech transfer leadership with GMP sites.
• Experience authoring risk assessments, technical docs and regulatory sources.

Responsibilities

• Lead commercial-stage comparability strategies supporting site transfers and process changes.
• Develop and lead tech transfer workstreams at GMP sites.
• Oversee documentation including transfer packages, change controls and techno-regulatory data.
• Provide on-site PiP support and drive CAPAs to resolution.
• Identify process trends and variability; drive improvements in yield and compliance.
• Manage deviations and change-control impact assessments with root-cause analysis.
• Collaborate with sites to ensure readiness for continuous GMP manufacturing.
• Travel up to 35%.

Skills

Technology transfer

GMP manufacturing

Validation/PPQ

Process control strategy

Deviation/change control

Commercial lifecycle management

Analytical troubleshooting

Data analysis

Cross-functional leadership

Technical writing

Education

B.S./M.S./Ph.D. in scientific or engineering discipline

Tools

JMP

Job description

Aurion Biotech is seeking a Principal Engineer, MSAT to lead technology transfer, comparability, and readiness of late-stage and commercial cell therapy products across GMP manufacturing sites. This individual contributor will drive complex workstreams, supervise technical documentation, and partner with sites to sustain robust, compliant processes.

The role requires 10+ years post-degree experience in MSAT or related functions, strong GMP knowledge, and the ability to work across