Senior Vice President, Manufacturing and Supply

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess, source, and oversee the network of contract manufacturers, cell collection centers, and contract development organizations.

• Review, negotiate, and execute significant contracts related to manufacturing, procurement, and logistics management for autologous and allogeneic CAR T therapies on a global scale.

• Establish and guide the manufacturing and supply chain functions, encompassing relationship management, technical oversight, contract negotiations, and supervision of external manufacturing and supply partners.

• Develop and manage the organization responsible for clinical supply, materials management, sourcing, and strategic sourcing for Kyverna's pipeline of cell therapies (both autologous and allogeneic).

• Recruit, hire, and nurture talent while evaluating, recommending, and implementing the organizational structure and capabilities essential for aligning with Kyverna’s strategic growth.

• Identify and lead the assessment of qualified organizations to deliver crucial services, materials, or products to Kyverna. Provide strategic insights, including capital planning and capacity management, and information to support the expansion of Kyverna’s global presence. Aid teams in constructing the complete business case, including risks, opportunities, and recommendations to foster Kyverna's growth.

• Direct Supply and Operations planning for all Kyverna products. Consolidate demand and ensure robust, agile supply strategies to meet that demand.

• Act as a Member/Leader for Kyverna in Joint Supply Committees (JSCs) with external supply chain members.

• Develop and oversee Business Operational reviews for the manufacturing and supply of all Kyverna products. Evaluate and communicate the performance heatmap of the entire supply chain components. Identify and escalate high-risk conditions, taking proactive steps to mitigate risks.

• Ensure network readiness for pivotal/registrational studies and launch/commercial supply activities.

• Develop and oversee manufacturing and supply chain operational budgets.

• Offer scientific and technical expertise and act as a Subject Matter Expert (SME) for manufacturing processes and technology adoption.

• Establish and enhance processes for monitoring and managing the performance of products produced across various supply points. Set performance expectations and manage the team to communicate and respond to signals of misalignment.

• Implement and manage supply orchestration systems for Kyverna to track, trace, and optimize the end-to-end patient journey, ensuring scheduling requirements are met and enhancing patient experience.

• Collaborate with CMC and product development teams on the creation of product history files, master files, site master plans, and validation plans.

• Stay informed about GMP/GTP and other relevant regulations, guidance documents, advisory committees, industry standards, and trends that impact current and future cell therapy development operations and products.

• Provide essential strategic compliance best practices to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and engagements with regulators.

⛳️ Requirements

• Bachelor’s degree or higher in Biochemistry, Chemical Engineering, Biotechnology, or a related field.

• Over 15 years of experience in pharmaceutical manufacturing, technology transfer, or process development, with a minimum of 5 years in leadership roles. Previous experience in Cell Therapy Manufacturing and Supply Chain management is essential.

• In-depth knowledge of cGMP manufacturing and regulatory requirements for biopharmaceutical products and Advanced Therapy Medicinal Products (ATMPs).

• Proven ability to manage multiple complex relationships within a Contract Manufacturing Organization (CMO) network.

• Capability to design and develop the manufacturing and supply function for Kyverna.

• Extensive knowledge and experience in managing manufacturing and supply operations for clinical trial products and aseptic processes, particularly in cell therapies.

• Strong critical thinking, troubleshooting, and problem-solving abilities.

• Exceptional interpersonal, verbal, and written communication skills.

• Ability to work efficiently and independently in a dynamic environment.

• Self-motivated and open to undertaking temporary responsibilities beyond the initial job description.

• Proven ability to manage and progress multiple projects simultaneously and dynamically adjust priorities as required.

• Demonstrated success in leading high-performing teams.

• Capacity to think creatively when addressing complex challenges.

• Effective communication skills with Kyverna Leadership, clinical, biomarker, biostatistical, pre-clinical scientists, and external business partners and Regulatory Authorities.

• A proactive self-starter who works well in team settings.

🏝️ Benefits

• Bonus

• Benefits

• Participation in the Company’s stock plan