Senior Engineer, MSAT

Fully Remote US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or IN applicants only

Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA.

$140,000 to $164,000

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites.

This role independently supports and may lead complex technical work streams supporting new site and suite readiness, technology transfer, feasibility and engineering runs, process implementation, risk assessments, GMP manufacturing support, comparability and validation activities, and ongoing process performance monitoring. The Senior Engineer serves as a technical and GMP manufacturing SME within assigned process areas and works closely with CDMOs and cross-functional partners to successfully transfer established manufacturing processes into compliant, robust, and sustainable commercial operations.

If you are a highly motivated and experienced GMP manufacturing professional with a passion for network expansion and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.

• Independently executes and supports technology transfer work streams for late-stage clinical and commercial manufacturing sites, including transfer planning, process implementation, site readiness, training, and execution.
• Independently executes and supports and may lead new site and suite readiness assessments, including facility fit and feasibility risk assessments, technical risk assessments, equipment readiness, process fit, personnel readiness, and process documentation.
• Author and support execution of technology transfer documentation, protocols, risk assessments, batch records, troubleshooting guides, process playbooks, change controls, training materials, etc.
• Collaborate with manufacturing sites and CDMOs to ensure technology, equipment, materials, personnel, procedures, and documentation are in place to support compliant and reliable GMP manufacturing.
• Provide on-site Person-in-Plan (PiP) technical support during feasibility, engineering, GMP, comparability, and validation campaigns; troubleshoot manufacturing issues and support timely resolution of technical problems, and GMP deviations.
• Identify and lead continuous improvement opportunities from form, fit, function risk assessments, to initiate change controls, to author transfer packages, and through to implementation at GMP manufacturing sites.
• Independently executes and supports implementation of process knowledge and the process control strategy at receiving manufacturing sites, including CPPs, CQAs, in-process controls, operating ranges, monitoring requirements, and escalation criteria.
• Establish manufacturing data capture and trending during technology transfer and transition to routine manufacturing. Perform statistical analysis using JMP or similar tools to evaluate process performance, variability, trends, and shifts.
• Ensure cross-functional alignment with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements.
• Other duties as assigned.

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA.

Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We…