Sr. Director, Process Development

Responsibilities

• 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.

Qualifications

• 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.