Senior Manager, Manufacturing and Supply

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 a Sr Manager, External Manufacturing and Supply in its Tech Ops 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.  

Reporting to the Director of External Manufacturing and Supply, the (Sr) Manager will be responsible for managing internal manufacturing compliance through the management of change controls and project execution, manufacturing procedure/workflow development, project management, execution of tasks as assigned and have PIP responsibilities within the network of CDMOs. They will execute tactical planning and provide project management support to ongoing continuous improvement opportunities.

• Perform Person-in-Plant activities within the network of CDMOs. Help coordinate schedule to ensure appropriate coverage for manufacturing activities.
• Act as technical Change Control facilitator, ensuring all required assessments are captured for the changes that originate from or impact the manufacturing and supply network. Ensures all scheduled activities occur as planned and all implementation actions are coordinated to ensure robust supply of product to patients.
• Use operational excellence mind-set and tools to review processes, procedures, and documentation to maintain simplicity, accuracy and robustness in the operational approach.
• While creating and improving documentation, process flows and internal business processes, the (Sr) Manager will proactively work with internal and external stakeholders to evaluate business needs and collaborates with and executes on projects as needed to support Manufacturing. Processes related to interfaces and coordination between Kyverna and its external CDMOs, interfaces with internal quality and supply chain to support improvements in Vein to Vein time, supporting regulatory filings and continuous improvement. Management and execution of all associated change controls as required.
• In collaboration with program teams, execute and support program goals, including document revision and process definition.
• Provide support for CDMOs and strategic suppliers to ensure overall program deliverables are achieved.
• Evaluate capabilities and industry best practices to identify new opportunities for optimization and innovation in clinical manufacturing.
• Participate in the creation and ongoing maintenance of an operations playbook of dashboards, metrics blueprints reports, and tools to help monitor and drive performance of CMOs and improve operational efficiency and execution.
• Building on industry standard benchmarking performance insights but tailoring to the needs of Kyverna, it’s products and the emerging field of Cell Therapy, implement tracking, analysis, and solutions to ensure operational excellence across key Suppliers / CMOs, including but not limited to, ensuring metrics (e.g., KPIs/KQIs/KRIs) are used to monitor vendor performance.
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
• Provide project management services with internal and external partners by developing agendas, setting priorities for discussions, capturing meetings minutes, and tracking action items across the governance model.
• Identify and document best practices for different partnerships to evaluate and implement with Kyverna’s Suppliers / CMOs and develop a supplier contact database.
• Participate in Risk Based Quality Management strategies in support of Kyverna’s clinical programs.
• Support business development due diligence projects as needed in order to support analysis and assessment of external opportunities.
• Travel as required to support PIP activity at various manufacturing CMOs up to 50% of the time.
• Other duties as assigned. 

• Degree (Bachelors or higher) or equivalent experience in life sciences, Biochemistry, Chemical Engineering, Biotechnology.
• 4+ years of pharmaceutical manufacturing, technology transfer & process development experience with at least 2 years experience in the field of cell therapies.
• Knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biopharmaceutical products and ATMPs.
• Knowledge and experience in managing manufacturing operations for clinical trial products and aseptic processes, with an emphasis on cell therapies.
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
• Strategic thinking and high emotional intelligence.
• Excellent interpersonal, verbal and written communication skills
• Ability to function efficiently and independently in a changing environment.
• Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
• Demonstrated success in leading high performing teams.
• Ability to communicate effectively with Kyverna Leadership and with external business partners and Regulatory Authorities.

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