Senior Principal Engineer, MSAT

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Senior Principal Engineer, MSAT

Fully Remote
• Remote (WA or MA preferred) - IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA only

JOB TITLE:
Senior 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, KY or WA.

REPORTS TO: Director, MSAT

SALARY RANGE: $180,000 to $202,000

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Senior Principal Engineer, MS&T individual contributor with deep technical expertise to provide technical management and leadership of a late-stage, commercial combination cell therapy product tech transfers. This individual will lead tech transfer activities including site readiness, new cleanroom expansions, new site tech transfers, risk assessments, preparation support for regulatory documents, comparability/validation campaigns, and ongoing process support to enable late-stage clinical and commercial manufacturing.

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.

• Tech transfer lead accountable for success of one or more tech transfers to manufacturing sites supporting late-stage clinical and commercial programs, overseeing CMC strategy implementation and managing CDMOs during tech transfer.
• Lead new site/suite readiness activities, including risk assessments, tech transfer strategy, planning, proactive risk mitigations, and execution of feasibility, engineering runs, comparability/PPQ runs.
• Provide strategic input on and author sections of CMC regulatory submissions. Provide immediate response support, as required.
• Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation are in place to support continuous GMP manufacturing. Ensure effective business continuity plans.
• Support GMP manufacturing execution, including on-site presence during initial campaign activities, PiP, troubleshooting issues, and driving investigations to closure.
• Own or support creation of key technical documents, including process control strategy, tech transfer plans, batch records, risk assessments, change/site comparability assessments, and change controls.
• 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.
• Deliver high-quality tech transfer to site GMP commercial readiness with accelerated timelines.
• Establish with site manufacturing data capture during tech transfer and ongoing trending. Perform data and statistical analysis with JMP, as required.
• Drive deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of GMP investigations.
• Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance.
• 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.
• Tran…