Remote Principal MSAT Engineer — Cell Therapy

Aurion Biotech Inc.; Massachusetts; Remote; USD 157,000 - 174,000; Full time

Benefits offered by this job

Robust Benefits

Total Rewards

Perks and Fun

Job summary

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. The Principal Engineer, MSAT will provide technical leadership for technology transfer, comparability, and commercial readiness across GMP manufacturing sites.

This individual contributor will lead complex workstreams spanning site readiness, tech transfer execution, comparability, lifecycle changes, and validation/PPQ support, partnering with GMP manufacturing sites to sustain

Qualifications

• BS/MS/PhD in a scientific or engineering discipline required.
• 10+ years with a BS; 7+ years with an MS; or 5+ years with a PhD of relevant industry experience.
• Experience in MSAT, Manufacturing, Process Development or related functions.
• Experience leading late-stage or commercial technology transfer workstreams with GMP sites.
• Experience with engineering/GMP manufacturing, validation/PPQ, deviations and investigations.
• Experience authoring risk assessments and regulatory documents; regulatory support preferred.
• Ability to lead cross-functional subteams and influence GMP partners.
• Cell therapy experience preferred; multiple sites/products a plus.

Responsibilities

• Lead technical execution of commercial-stage comparability strategies for site transfers.
• Develop workstreams for late-stage and commercial process changes at GMP sites.
• Lead tech transfers including transfer planning, risk assessments, training, and GMP readiness.
• Own documentation such as tech transfer packages, change controls, risk assessments, reports.
• Provide on-site PiP support, drive investigations, deviations, and CAPAs to resolution.
• Analyze manufacturing data to identify variability and opportunities for improvement.
• Manage deviation and change-control impact assessments and timely closures.
• Collaborate with sites to ensure manufacturing readiness and business continuity.

Skills

Technology transfer

Commercial comparability

GMP manufacturing

Validation/PPQ

Process control strategy

Data analysis

Cross-functional collaboration

Regulatory documentation

JMP

Education

BS, MS, or PhD in a scientific or engineering discipline

Tools

JMP

Job description

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. The Principal Engineer, MSAT will provide technical leadership for technology transfer, comparability, and commercial readiness across GMP manufacturing sites.

This individual contributor will lead complex workstreams spanning site readiness, tech transfer execution, comparability, lifecycle changes, and validation/PPQ support, partnering with GMP manufacturing sites to sustain