Senior MSAT Engineer - Remote Cell Therapy & Tech Transfer

Aurion Biotech; Washington (Washington County); Remote; USD 140,000 - 164,000; Full time

Benefits offered by this job

Full health insurance

401(k) matching

EAP

FSA

Generous PTO

Paid parking

Subsidized commuter passes

In-office catered lunches

Team events

Community projects

Job summary

Aurion Biotech is seeking a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites. The role independently leads complex technical workstreams, serves as a GMP manufacturing SME within assigned process areas, and partners with CDMOs and cross‑functional teams to ensure transfer into compliant, robust operations.

If you are a motivated GMP manufacturing professional with experience in tech transfers,

Qualifications

• Bachelor’s, Master’s, or PhD in a science or engineering discipline.
• 7+ years of industry experience; 4+ years with MS or PhD.
• Experience in MS&T, manufacturing, or process development for biologics/cell therapies.
• Experience with technology transfers for biologics, cell therapies, or other complex processes.
• Experience working with CDMOs or external manufacturing sites.
• Solid understanding of cGMP, ICH guidelines, and regulatory expectations.

Responsibilities

• Independently execute/ support technology transfer workstreams for late-stage clinical and commercial manufacturing sites.
• Lead site readiness assessments including facility fit, risk assessments, equipment readiness, and process documentation.
• Author and support documentation: protocols, risk assessments, batch records, troubleshooting guides, change controls, training materials.
• Collaborate with manufacturing sites and CDMOs to ensure compliant and reliable GMP manufacturing.
• Provide on-site PiP technical support during feasibility, engineering, GMP, comparability, and validation campaigns; troubleshoot issues and GMP deviations.
• Identify and lead continuous improvement opportunities from risk assessments to change controls and implementation.
• Implement process knowledge and control strategy at receiving sites (CPPs, CQAs, in-process controls, ranges).
• Establish manufacturing data capture and trending; perform statistical analysis to evaluate performance and trends.
• Ensure cross-functional alignment with Process Development, External Manufacturing, Quality, Regulatory, and Supply Chain.
• Other duties as assigned.

Skills

Technical writing

Communication

Cell therapy familiarity

Independent ownership

Risk assessment (FMEA)

Analytical/problem-solving

Deviation management/ CAPA

Cell culture manufacturing

Data analysis tools (JMP, Excel)

Education

BS/MS/PhD in science or engineering

Tools

JMP

Excel

Job description

Aurion Biotech is seeking a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites. The role independently leads complex technical workstreams, serves as a GMP manufacturing SME within assigned process areas, and partners with CDMOs and cross‑functional teams to ensure transfer into compliant, robust operations.

If you are a motivated GMP manufacturing professional with experience in tech transfers,