Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Kyverna is recruiting an IT GxP Business Systems Analyst in its Information Technology organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.
Reports to: Director, Business Applications
Location: Emeryville, CA (Hybrid – in office twice a week - Tuesday/Wednesday)
Responsibilities
Evaluate and continuously improve GxP R&D, Clinical and Commercial systems to ensure efficiency, scalability, and compliance with company needs.Document and analyze the current business processes and workflows to identify opportunities for improvement and automation to reduce manual processes.Partner with business leaders to understand their needs, develop business cases for new system implementations or enhancements, including cost-benefit analysis and return on investment (ROI) calculations.Lead end-to-end system selection and implementation projects, including request for projects, requirements gathering, system configuration, testing, training, and post-go-live support.Create change controls and lead system upgrades, patches, and enhancements to maintain system functionality and security compliance.Ensure the accuracy and integrity of GxP data through system audits and reconciliations.Develop and maintain dashboards and reports for leadership to provide insight into business performance and operational metrics.Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards.Implement, document, and maintain proper security protocols to safeguard sensitive company information, such as patient data, employee information, and proprietary biotech research.Serve as the first point of contact for troubleshooting and resolving issues related to GxP systems.Requirements
Bachelor’s degree in Business, Information Technology, Computer Science, Finance, or a related field. MBA or MS degrees preferred.7+ years of experience as a Business Systems Analyst or similar role, preferably within a biotech, life sciences, or public company.Excellent communication skills to work with cross-functional teams (Clinical, Commercial, Regulatory, Patient Operations, Supply Chain, Manufacturing, Quality, IT) and explain technical details to non-technical stakeholders.Experience supporting Clinical, Regulatory, Commercial, and Quality systems (e.g. CRM, RIMS, DMS, QMS, TMS, LIMS).Strong knowledge of SQL, data analytics tools, and reporting systems (e.g., Power BI).Experience in system integrations, configuration, testing, and supporting GxP software solutions.Regulatory Knowledge: Strong understanding of regulatory requirements relevant to GxP environments, including FDA regulations, EU Annex 11, and 21 CFR Part 11 compliance.Ability to perform gap analysis, gather requirements, and design efficient solutions for GxP business processes.Understanding of Drug Development Process and Cell/Gene Therapy principles.Strong analytical skills to understand complex business processes and system requirements:
Ability to translate business needs into technical requirements and system solutions.Expertise in process improvement and finding efficiencies within existing systems and processes.Strong project management skills with the ability to work on multiple projects simultaneously.Ability to influence and collaborate with senior leadership and stakeholders.Excellent organizational skills and attention to detail.Customer-focused mindset with a proactive approach to solving issues.Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
