Senior MSAT Engineer - Remote Cell Therapy Tech Transfer

Aurion Biotech, Inc.; Northern (KY); Hybrid; USD 180,000 - 202,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

EAP / FSA

Paid time off

Paid parking

Commuter benefits

In-office catered lunches

Job summary

Aurion Biotech, Inc. is seeking a Senior Principal Engineer, MSAT to lead tech transfer for late-stage clinical and commercial programs.

You will drive site readiness, risk assessments, and feasibility runs, coordinating with CDMOs and internal teams to ensure GMP manufacturing readiness. The role requires deep MSAT expertise, experience with regulatory submissions, and the ability to manage cross-functional teams across manufacturing, QA, and regulatory.

Qualifications

• Experience in MS&T, Manufacturing or Process Development for biologics/cell therapies.
• Lead tech transfers including cross-site readiness, risk assessments, PPQ/comparability.
• Experience authoring and defending CMC sections of regulatory submissions and interacting with regulatory bodies.

Responsibilities

• Tech transfer lead accountable for success of tech transfers to manufacturing sites.
• Lead site readiness activities including risk assessments and feasibility runs.
• Provide strategic input on CMC regulatory submissions and regulatory responses.
• Collaborate with sites to ensure GMP manufacturing readiness and business continuity.
• Support GMP manufacturing execution and on-site activities during initial campaigns.
• Create and oversee key technical documents: tech transfer plans, batch records, risk assessments, CCAs.

Skills

MSAT

Tech transfer

Cross-functional teams

CDMOs management

GMP

Education

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

Tools

JMP

Job description

Aurion Biotech, Inc. is seeking a Senior Principal Engineer, MSAT to lead tech transfer for late-stage clinical and commercial programs.

You will drive site readiness, risk assessments, and feasibility runs, coordinating with CDMOs and internal teams to ensure GMP manufacturing readiness. The role requires deep MSAT expertise, experience with regulatory submissions, and the ability to manage cross-functional teams across manufacturing, QA, and regulatory.