Sr. Director, Process Development

Kyverna is seeking a Sr. Director, Process Development to lead a team of scientists and engineers responsible for the development of robust processes used to isolate, modify, expand, and purify autologous engineered T-cell products. This individual develops the overall process optimization and innovation strategy, leads the technical transfer of process improvements to external partners, authors/reviews regulatory documents, aligns plans with health authorities, and supports the manufacture of clinical and commercia supplies. This individual designs experiments and creates objectives, timelines, resource plans, and budgets to support the company’s goals. The role requires strong partnership with functions within technical operations including Analytical Development, Quality, and Manufacturing, and with other internal and external stakeholders. The ideal candidate has a strong technical background in late-stage/commercial cell therapy development, approval and commercialization, and has strong leadership, strategic planning, communication, and project management skills.

Department: Technical Development
Location: Emeryville, CA (Hybrid: 2 days a week) 
Reports To: Executive Director, Head of Technical Development

• Identify life-cycle management process improvement options that improve robustness, increase capacity, and reduce cost of goods to support the company’s aspirations to be the leader in the autoimmune CAR T space.
• Partner with the life-cycle team leaders, clinical development, commercial, and business development teams to create the optimization and innovation roadmap.
• Identify opportunities for team synergies and/or product improvements across different products and platforms.
• Lead the process development function including the in-house laboratories.
• Manage the design and execution of process development plans, including studies that support pre-clinical and clinical development stages.
• Design process characterization plans and process control strategies.
• Support the optimization of plasmids, vectors, and product delivery methods.
• Lead the execution of laboratory studies, technical assessments for engineering and process changes, and documentation generation pertaining to process development, qualification, and validation.
• Oversee the execution of studies that support process development, process characterization, and life-cycle change management to ensure on time delivery of projects.
• Author and review process related documents, including risk assessments, technical protocols and reports, batch records, change controls, investigation reports, and corrective and preventative actions.
• Author and review CMC sections of regulatory documents in support of both clinical trial (IND/IMPD) and commercial therapeutic applications (BLA/MAA).   
• Product Supply Strategy
• Support the characterization of critical raw materials (cell banks, plasmids, reference standards, etc.).
• Support the creation of the product supply strategy, including assessments for in-house versus outsourced activities.
• Design processes that ensure compliance with Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Manage the tech transfer for clinical and commercial manufacturing.
• Team Leadership and Development
• Build a high functioning and performing team that’s delivers meaningful results.
• Foster a culture of innovation, collaboration, and continuous improvement.
• Provide mentorship, guidance, and career development opportunities for team members.
• Regulatory and Quality Compliance
• Ensure all development activities comply with regulatory standards, including expectations from FDA, EMA, and other global health authorities.
• Collaborate with the Quality team to implement and maintain SOPs, quality systems, and documentation.
• Develop and manage the overall process development budget operational and capital expenses and resource plan.
• Allocate resources effectively to meet project timelines and objectives.
• Collaboration and Communication 
• Establish and ensure strong relationships with key partners in Analytical Development, Manufacturing, Quality, Clinical and Regulatory. 
• Function as a key liaison with internal and external stakeholders on process development topics.
• Develop and maintain relationships with contract development and manufacturing organizations (CDMOs) and other external partners.
• Serve as the accountable technical interface between Kyverna Process Development and the process development department of CDMO partners.
• Represent the company in interactions with regulatory agencies, industry conferences, and scientific meetings.

• Advanced degree (PhD) in cell biology, Immunology, Molecular Biology, Chemical Engineering, Biotechnology or equivalent is preferred.
• 15+ years of experience in the biotechnology or pharmaceutical industry with a focus on late-stage/commercial cell therapy, biologics, or related field
• Proven expertise in CAR-T (or other ex-vivo gene modified) cell therapy process development, process characterization, tech transfer and comparability assessment.
• Knowledge of regulatory requirements and quality standards for cell therapies.
• Experience advancing product development on closed automated platforms or practical know-how of application of process automation in support of cell therapy processes is preferred. 
• Established track record of success supporting early and late-stage CMC and clinical product development teams.
• Expertise with cGMP manufacturing as well as associated regulations and requirements for pharmaceuticals and devices.
• Excellent interpersonal, verbal and written communication skills.
• Ability to function efficiently and independently in a changing environment.
• Ability to foster a strong team-first environment to enable delivery of company goals.
• Demonstrated success in leading high performing development teams and growing talent.
• Demonstrated capacity to think creatively when addressing complex situations. 
• Ability to collaborate and communicate effectively with Kyverna Leadership, Analytical Development, Manufacturing, Quality, Clinical and Regulatory teams and with external business partners and Regulatory Authorities.