Senior Cold Chain Engineer
About The PositionThe 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 ResponsibilitiesCold Chain System Design & EngineeringDesign, 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 solutionsDefine temperature excursion tolerances, hold times, and stability-aligned packaging strategies.Operational Readiness & Scale-UpBuild 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 variabilityServe as the cold chain SME during process development, tech transfer, and scale-up initiatives.Qualification, Validation & Risk ManagementLead 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 & DocumentationEnsure cold chain operations comply with GxP, and internal quality standards.Partner with Quality to develop and maintain:SOPs, work instructions, and deviation response playbooksTemperature excursion investigation frameworksSupport audits, inspections, and regulatory readiness activities related to cold chain operations.Vendor & External Partner ManagementAct 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 ImprovementDefine 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 geographiesCross-Functional LeadershipServe 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 assignedRequirementsQualifications And EducationTo 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 methodologiesRequired Skills And AbilitiesHands-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.