Senior Vice President, Manufacturing and Supply

Responsibilities

Reporting to the Chief Technology Officer, the candidate will:

• Evaluate, source and manage the network of contract manufacturers, cell collection centers, and contract development organizations.
• Evaluate, negotiate and implement major contracts related to manufacturing, procurement and logistics management for autologous and allogeneic CAR T therapies globally.
• Build and lead the manufacturing function and supply chain function, including relationship, technical management, contract negotiation and oversight of our external manufacturing and supply organizations.
• Build and lead the organization to provide and manage clinical supply, materials management, sourcing and strategic sourcing for the pipeline of cell therapies (both autologous and allogeneic) for Kyverna.
• Recruit, hire, and develop employees, and assess, recommend, and implement the structure and capabilities needed to grow the function in step with Kyverna’s strategic growth.
• Source and lead the evaluation of qualified organizations to provide critical services, materials, or products to Kyverna. Provide strategic input, including capital planning and capacity management, and information supporting the expansion of the Kyverna footprint globally. Assist teams in building the full business case with risks, opportunities and recommendations that support the growth of Kyverna.
• Lead the Supply and Ops planning for all products at Kyverna. Aggregate demand and ensure robust and agile supply strategies to meet demand.
• Participate as Member/Leader for Kyverna on JSCs with external members of the supply chain.
• Develop and lead the Business Operational reviews for manufacturing and supply of all Kyverna products. Assess and communicate the performance heatmap of the components of the entire supply chain. Escalate conditions of high risk and actively intervene to mitigate risks.
• Ensure network readiness for pivotal/registrational studies and launch/commercial supply activities. 
• Develop and manage manufacturing and supply chain operational budget(s)
• Provide scientific and technical guidance and serve as SME for manufacturing processes and technology adoption.
• Establish and build the process for process monitoring and performance management of products produced in multiple supply points.  Set the expectations for performance of this capability and manage the team to communicate and respond to signals indicating out-of-alignment conditions.
• Implement and operate the supply orchestrations systems for Kyverna to track, trace, and adjust the end-to-end patient journey, meeting scheduling requirements and optimizing patient experience.
• Support CMC and product development teams through collaboration on development of product history files, master files, site master plans and validation plans.
• Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends applicable to current and future cell therapy development operations and products.
• Provide key strategic Compliance best business practices to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.  

Requirements

• Degree (Bachelor or higher) in Biochemistry, Chemical Engineering, Biotechnology or equivalent
• 15+ years of pharmaceutical manufacturing, technology transfer or process development experience with at least 5 years’ experience in leadership roles. Prior experience with Cell Therapy Manufacturing and Supply Chain management is required.
• Expertise with cGMP manufacturing as well as regulatory requirements for biopharmaceutical products and ATMPs
• Demonstrated ability to manage multiple complex relationships with CMO network
• Ability to design and build the manufacturing and supply function for Kyverna
• Deep knowledge and experience in managing manufacturing and supply 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
• Excellent interpersonal, verbal and written communication skills
• Ability to function efficiently and independently in a changing environment
• Self-motivated and willing to accept temporary responsibilities outside of the initial job description
• The ability to manage and advance multiple projects simultaneously and dynamically reprioritize as needed
• Demonstrated success in leading high performing teams.
• Demonstrated capacity to think creatively when addressing complex situations 
• Ability to communicate effectively with Kyverna Leadership, clinical, biomarker, biostatistical, and pre-clinical scientists, and with external business partners and Regulatory Authorities.
• Self-starter, works effectively in teams