Director of Laboratory Science (Denver)
ABOUT US: At Vitrafy Life Sciences, we’re not just part of the biotech industry, we’re redefining it by improving the quality of healthcare treatments by providing effective cryopreservation solutions. Our breakthrough cryopreservation technologies could create new global standards in the way biological materials are preserved, transported, and delivered, ultimately helping preserve life. Our innovative cryopreservation technology provides solutions spanning cryopreservation devices, packaging and an integrated software platform, LifeChain™, focused on retaining the quality of biological material across the entire cryopreservation supply chain. ABOUT THE ROLE: Reporting to the Chief Scientific Officer, you will lead the design, execution, and interpretation of internal proof-of-concept and feasibility studies while overseeing external verification and validation (V&V) programs conducted with CROs, blood centers, and other research partners. This is a hands-on scientific leadership role. You will work closely with Laboratory Science, R&D, Engineering, Quality, and Regulatory teams to translate scientific findings into product development decisions, design inputs, V&V strategies, and regulatory-ready technical documentation. What You’ll Be Doing Provide scientific and technical leadership across laboratory activities supporting the development and testing of Vitrafy’s blood product devices. Design, conduct, and interpret proof-of-concept, feasibility, and verification & validation (V&V) studies. Translate scientific findings into actionable recommendations for R&D, Engineering, Quality, and Regulatory teams. Lead day-to-day laboratory operations, including equipment, reagent, and material qualification. Author and approve study protocols, technical reports, and laboratory documentation supporting design history files and regulatory submissions. Identify, qualify, and manage CROs, blood centers, and external testing partners supporting analytical, performance, biocompatibility, and clinical-sample studies. Oversee external V&V programs, including study design, protocols, timelines, budgets, data quality, and technical deliverables. Build and maintain relationships with blood centers to support blood and blood-component sourcing, specimen logistics, and testing activities. Critically evaluate study data, statistical analyses, and technical reports for scientific rigor and regulatory readiness. Hire, mentor, and lead laboratory personnel while building scalable laboratory capabilities as Vitrafy grows. Foster a culture of scientific excellence, quality, accountability, and continuous improvement. Collaborate closely with R&D, Engineering, Quality, Regulatory, and external partners and represent Vitrafy at industry and scientific events as required. ABOUT YOU: 10 years of progressive laboratory experience in blood products, blood product devices, or transfusion medicine testing, including both hands-on laboratory work and oversight of externally executed studies. Demonstrated experience designing and executing proof-of-concept or feasibility studies and verification and validation studies for a device or biologic in development. Direct experience with electronic quality management systems, design history files, and regulatory submissions. Experience managing CROs or other external testing partners, including scope-of-work development, protocol review, budget and timeline management, and data package review. Strong experience recording, analyzing, interpreting, and communicating scientific data. Experience collaborating with multidisciplinary technical teams and external scientific partners. Experience working autonomously while also contributing as part of a broader research and product development team. Knowledge of the safe handling of blood, blood-derived materials, and other potentially hazardous biological substances. Strong vendor and contract management skills, including the ability to hold external partners accountable for timelines and data quality. Working knowledge of FDA design control requirements (21 CFR 820.30 / QMSR), ISO 13485, and ISO 14971. Highly Regarded Master’s degree in Microbiology, Biology, Biomedical Science, Biomedical Engineering, or a related discipline. ASCP Board of Certification as a Specialist in Blood Banking (SBB) or Blood Bank Technologist/Scientist (BB), or completion of an AABB-accredited Specialist in Blood Bank Technology program. Previous laboratory experience within the medical device, blood product, diagnostics, or biologics sectors. Experience managing multiple concurrent CROs or external study partners within a medical device or biologics commercial-development environment. ASQ Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), or ISO 14971 risk-management training. PMP certification or equivalent project-management experience. Key Competencies Hands-on scientific leadership and strong technical credibility. Ability to operate effectively in a high-growth, fast-paced environment. Strong analytical and practical problem-solving skills. Ability to translate complex scientific findings into clear, actionable recommendations. Strong interpersonal, written, and verbal communication skills. Ability to build collaborative relationships across scientific, technical, commercial, and executive teams. High standards of accountability, quality, and transparency. Continuous improvement and growth mindset. Willingness to travel as required. We anticipate this requisition will be open for a minimum of five days, from August 14, 2026. We encourage your prompt application. The Perks!: Our benefits include medical, dental, and vision plan options. We also support long-term financial well-being through a 401(k) plan, along with unlimited vacation and sick time programs to help employees maintain a healthy balance between work and life. Ready to Preserve the Future with Us? If you're ready to join a fast-growing biotech leader where your work drives global change, Vitrafy Life Sciences is your next move.
