RA, Process Data Management

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 a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Kyverna is navigating what’s next in the synthetic biology, immunology and cell engineering to create a new class of T-cell therapies programmed to target and selectively modulate the underlying causes of autoimmunity. Join the front lines of a cell therapy revolution where scientists, industry veterans and healthcare visionaries are creating a new class of living medicines for autoimmune disease. We are seeking a highly motivated (Sr.) Research Associate to join our team developing novel and innovative engineered T cell-based therapies for autoimmune diseases. The ideal candidate will contribute to our goals of navigating what’s next in immunology while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why. 

Responsibilities

• Candidate will assist with implementation of the Process Monitoring Program (PMP), including assisting in installation and validation of any data management tools, including databases, data lakes, and any analysis software.
•  Candidate be responsible for ensuring timely manufacturing process data entry, transcription, and verification.
• Candidate will under the direction of manufacturing and technical development leadership to develop and maintain data dashboards and visualizations
• Candidate will aggregate data from source documents into storage software ranging from Microsoft Excel to proprietary secured databases
• Candidate will run cursory analysis in statistical software including JMP, GraphPad Prism, R Studio, and/or be proficient in high-level programming to execute statistical analysis
• Candidate will work closely with third parties and internal Information Technology management to implement and manage software tools as appropriate
• Candidate will assist the MS&T and Process Validation leads to establish process characterization and validation methods as part of product life-cycle management and Quality-by-Design

Requirements

• B.S. or M.S degree in statistics, data science, biochemical engineering, or relevant life science with a strong statistical background
• 2+ years experience in life sciences data management and statistical analysis, including prior experience working with structured databases and SQL.
• 2+ years of relevant life science laboratory/manufacturing experience, including process development, analytical development, quality control, and/or manufacturing.
• Proficiency with common data science programming languages, including R, SQL, python, and/or java.
• Experience in development of cell therapy or biological manufacturing is preferred, including a working knowledge of cell isolation, gene editing, cultivation, formulation, and cryopreservation methods.
• Experience working within the Chemistry, Manufacturing, and Control (CMC) function and with a fundamental understanding of regulatory CMC principles is preferred.
• Experience in a GMP setting is preferred.
• Excellent organizational skills, meticulous record-keeping, and keen attention to detail
• Demonstrated team player with good communication and interpersonal skills.
• Ability to troubleshoot and develop creative solutions to near-constant challenges associate with early-stage process development.
• Position may require occasional travel

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