Principal Engineer, MSAT

Aurion Biotech

. Lead technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment, or material changes .

Posted 10/20/2026full-timeRemote • United StatesLead💰 $157,000 - $174,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in leading technical execution of comparability strategies and technology transfer within GMP environments, with a strong focus on process development and regulatory compliance for biologics and cell therapies.

Highest-signal resume keywords

GMP Manufacturing ExperienceTechnology Transfer LeadershipComparability Strategy DevelopmentRisk Assessment AuthoringCross-Functional Team Leadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Technical Risk AssessmentProcess Control StrategyStatistical Data AnalysisTechnical Documentation AuthoringDeviation ManagementChange Control ManagementManufacturing InvestigationsGMP ComplianceCommercial Lifecycle ManagementValidation/PPQ

Soft Skills

Analytical SkillsTroubleshooting SkillsMentoring SkillsInfluencing SkillsCollaboration Skills

Industry Keywords

Cell TherapyBiologicsICH GuidelinesCommercial ComparabilityManufacturing Site TransfersTechnical InvestigationsRegulatory SubmissionsGMP Subject Matter ExpertEngineering RunsProcess Implementation

About the role

Key responsibilities & impact

Lead technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment, or material changes
Develop and lead technical workstreams for late-stage and commercial process changes at GMP sites
Conduct technical risk assessments, change controls, impact assessments, comparability considerations, and GMP implementation
Lead late-stage and commercial technology transfer workstreams, including transfer planning, facility/process fit, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness
Own or support technology transfer packages, change controls, technical risk assessments, comparability plans/data packages/reports, process control strategy, execution protocols/reports, batch records, and regulatory source documents
Provide on-site PiP support, troubleshoot process issues, and drive technical investigations, deviations, change controls, and CAPAs to resolution
Establish and evaluate manufacturing data and process performance trends using statistical tools
Identify variability, shifts, and opportunities to improve process consistency, yield, robustness, and compliance
Manage deviation and change-control impact assessments, root-cause analysis, and timely closure of tech transfer investigations
Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation support continuous GMP manufacturing
Ensure effective business continuity plans
Serve as a technical and GMP subject matter expert within cross-functional technical execution
Partner with GMP manufacturing sites to transfer and sustain robust, compliant commercial manufacturing processes

Requirements

What you’ll need

B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required
10+ years with a B.S.; 7+ years with an M.S.; or 5+ years with a Ph.D. of relevant industry experience
Significant experience in MSAT, Manufacturing, Process Development, or related functions supporting late-stage or commercial biologics or cell therapies
Demonstrated commercial-stage comparability, including comparability supporting manufacturing site transfers, process, equipment, or material changes, or other post-approval/lifecycle manufacturing changes
Demonstrated experience leading late-stage or commercial technology transfer workstreams and working directly with GMP manufacturing sites
Experience with engineering/GMP manufacturing, validation/PPQ, technical deviations, and manufacturing investigations
Experience authoring risk assessments, technical documentation and source documents supporting CMC regulatory submissions
Experience supporting regulatory responses or inspections preferred
Experience leading cross-functional technical subteams and influencing GMP manufacturing partners through complex technical issues and implementation
Cell therapy experience strongly preferred
Experience across multiple commercial manufacturing sites or products a plus
Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies
Strong knowledge of technology transfer, commercial comparability, GMP manufacturing, validation/PPQ, process control strategy, deviation/change control, and commercial lifecycle management
Ability to independently lead complex technical workstreams, implement commercial lifecycle changes, and develop technical approaches with limited direction
Strong technical writing and document review skills
Strong analytical, troubleshooting, and data-analysis skills
Ability to lead cross-functional technical subteams, influence external manufacturing partners, and mentor junior technical staff without direct management responsibility
Background in cell therapy, viral vector, or other complex biologic modalities with hands-on GMP manufacturing experience preferred
Travel required up to 35%

Benefits

Comp & perks

Full health insurance for employees and their families
401(k) matching
Employee Assistance Program (EAP)
Flexible Spending Account (FSA)
Generous PTO
Paid parking
Subsidized commuter passes
In-office catered lunches
Team events
Community projects
Competitive compensation packages