Principal Engineer, MSAT

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

Description

JOB TITLE:
Principal Engineer, MSAT

LOCATION: 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, MS, WI, KY or WA.

REPORTS TO:
Director, MSAT

SALARY RANGE: $157,000 to $174,000

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Principal Engineer, MSAT to provide technical expertise for technology transfer, comparability, and commercial readiness of late-stage and commercial cell therapy products at GMP manufacturing sites.
This individual contributor will independently lead complex technical work streams spanning site readiness, tech transfer execution, comparability, lifecycle changes, and validation/PPQ support. The Principal Engineer will serve as a technical and GMP SME within cross-functional technical execution, and partner closely with GMP manufacturing sites to transfer and sustain robust, compliant commercial manufacturing processes. If you are a highly motivated and experienced GMP manufacturing professional with a passion for commercializing innovative drug therapies in GMP operations, we encourage you to apply for this exciting opportunity to join our team.

• Lead technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment or material changes, etc.
• Develop and lead technical work streams for late-stage and commercial process changes implementation at GMP sites, including technical risk assessments, change controls, impact assessments, comparability considerations, and GMP implementation.
• Lead complex work streams within late-stage and commercial tech transfers, including transfer planning, facility/process fit, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness.
• Own or support technical documentation, including 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, ensuring robust root-cause analysis and timely closure of tech transfer investigations.
• Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation are in place to support continuous GMP manufacturing. Ensure effective business continuity plans.
• 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 are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship
  :
  We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation
  :
  We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit
  :
  We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit  .

We want our people to wake up…