JOB TITLE: Senior Cold Chain Engineer

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

REPORTS TO: Director, Supply Chain & Logistics

SALARY RANGE: $129,000 to $155,000

ABOUT THE POSITION

The Senior Cold Chain Engineer will own the design, implementation, optimization, and continuous improvement of LN2 and temperature-controlled supply chain systems supporting research, clinical, and future commercial operations. This role is highly autonomous and requires deep technical expertise, strong project execution skills, and the ability to translate scientific and regulatory requirements into scalable operational solutions. They will be expected to be the primary supply chain contact for various internal and external teams, representing the team in many high-profile projects.

KEY RESPONSIBILITIES

Cold Chain System Design & Engineering

• Design, qualify, and optimize LN2, cryogenic, frozen, refrigerated, and CRT cold chain systems across internal and external networks.
• Lead the selection, qualification, and lifecycle management of: LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
• Define temperature excursion tolerances, hold times, and stability-aligned packaging strategies.

Operational Readiness & Scale-Up

• Build cold chain capabilities to support R&D, clinical trials, and future commercial scale.
• Develop and execute cold chain strategies aligned with Long-term storage requirements and global distribution and site variability
• Serve as the cold chain SME during process development, tech transfer, and scale-up initiatives.

Qualification, Validation & Risk Management

• Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities.
• Author and review validation protocols, reports, and technical assessments.
• Conduct failure mode and risk analyses for cold chain processes and shipping lanes.
• Design and implement mitigation strategies for LN2 and CO2 supply interruptions, equipment failures, and transit risks.

Quality, Compliance & Documentation

• Ensure cold chain operations comply with GxP, and internal quality standards.
• Partner with Quality to develop and maintain:
• SOPs, work instructions, and deviation response playbooks
• Temperature excursion investigation frameworks
• Support audits, inspections, and regulatory readiness activities related to cold chain operations.

Vendor & External Partner Management

• Act as the technical lead for cold chain vendors, couriers, and logistics providers.
• Evaluate vendor capabilities, lead technical due diligence, and support contracting decisions.
• Drive continuous improvement through performance reviews, root-cause investigations, and CAPAs in alignment with Quality.

Data, Monitoring & Continuous Improvement

• Define KPIs and dashboards for cold chain performance (excursions, lane reliability, cost, recovery time).
• Leverage temperature data, shipment analytics, and trend analysis to proactively improve system robustness.
• Champion standardization and best-practice adoption across programs and geographies

Cross-Functional Leadership

• Serve as the cold chain subject-matter expert across Supply Chain, Manufacturing, Quality, Clinical Ops, Commercial Ops, and R&D.
• Translate scientific, regulatory, and operational needs into executable cold chain solutions.
• Independently identify gaps, propose solutions, and drive projects from concept through implementation.
• Performs other duties as assigned

ABOUT AURION BIOTECH 

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 www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in engineering, supply chain, life sciences, or related technical field (required). Master's degree in engineering, supply chain, life sciences, or related technical field (preferred).
• 7–12+ years of experience in cold chain engineering, logistics, or operations within biotech, pharma, cell/gene therapy, or biologics.
• Relevant certifications a plus: Cold Chain or GDP certifications Six Sigma / Lean methodologies

REQUIRED SKILLS AND ABILITIES

• Hands-on experience with LN2 and cryogenic cold chains (storage, shipping, and monitoring) with biologics.
• Proven track record of owning complex technical projects end-to-end with minimal oversight and ability to operate independently. 
• Direct experience with packaging qualification, lane validation, and temperature excursion management.
• Proficiency in Microsoft Office Suite, DocuSign, and Smartsheet.