Principal MSAT Engineer (Remote) – GMP Manufacturing

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

Benefits offered by this job

Full health insurance for employees &

401(k) matching

Paid parking

Subsidized commuter passes

Job summary

Aurion Biotech is seeking a Principal Engineer, MSAT, to drive technology transfer, comparability, and commercial readiness for late-stage and commercial cell therapies at GMP manufacturing sites.

The role leads complex workstreams spanning site readiness, tech transfer execution, validation support, and lifecycle changes, partnering with multiple manufacturing sites to sustain compliant processes.

Qualifications

• MSAT-focused expertise in late-stage or commercial biologics/ccell therapies.
• Experience leading tech transfers and GMP manufacturing collaborations.
• Experience with risk assessment, change control, and regulatory documentation.
• Strong technical writing, data analysis, and cross-functional leadership.

Responsibilities

• Lead technical execution of comparability strategies for site transfers and changes.
• Drive late-stage and commercial tech transfer workstreams with GMP readiness.
• Own technical documentation: tech transfer packages, risk assessments, and reports.
• Provide on-site PiP support, troubleshoot, and drive CAPAs to resolution.

Skills

MSAT

Manufacturing

Process Development

Cross-functional collaboration

Technical writing

Statistics (JMP)

Education

B.S./M.S./Ph.D. in science or engineering

Tools

JMP

Job description

Aurion Biotech is seeking a Principal Engineer, MSAT, to drive technology transfer, comparability, and commercial readiness for late-stage and commercial cell therapies at GMP manufacturing sites.

The role leads complex workstreams spanning site readiness, tech transfer execution, validation support, and lifecycle changes, partnering with multiple manufacturing sites to sustain compliant processes.