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.
Title: Quality Control Consultant - External Operations
Location: Emeryville (Hybrid) - Two days onsite per week
Assignment length: Approximately 6+ months
We are seeking a Quality Control Consultant - External Operations to serve as a member of the Quality organization working closely with external analytical testing groups and contract testing laboratories to advance Kyverna’s candidate, and future clinical pipeline products.
The successful candidate will provide leadership, representation, and support to internal and external teams to proactively identify gaps and execute date-to-date interaction with external CTLs and CDMOs ensuring compliant GMP analytical testing. This position supports manufacturing (raw materials, in-process, release) and is responsible for stability, critical reagent, and reference standard programs. Participation in the selection and qualification of analytical vendors, as needed, will be expected.
This role will be expected to review and compile data from a broad variety of analytical method and techniques and collating into documentation, including certificates of analysis and reports, as well as setting specifications and creating stability protocols, etc. The successful candidate will be responsible for providing compliance input into investigations associated with GMP method execution, ensuring proper investigation into the root cause of product failures and assisting in determining appropriate product disposition and/or process improvements. Oversight of method performance metrics, including trending analyses, is expected, as is ensuring compliance with compendial requirements for applicable methods.
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
