Director, Process Development

Responsibilities

• Provide process development leadership for new process development, optimization of existing processes, associated process equipment, technology transfer, and support for GMP manufacturing of engineered T cell therapy products.

• Own process development, including the process development plan, process design, FMEA, study oversight (design, execution of studies, and delivery of reports), and with a track record of delivering these on time and in full.  

• Lead process-related risk assessments, process characterization plans, and development of process control strategies.

• Lead and mentor a team of scientists and engineers through strong leadership, collaboration, and a results-driven mindset.

• Serve as the primary responsible and accountable leader for the execution of wet lab process development and process characterization activities.

• Define and lead laboratory studies and technical assessments for engineering and process changes, and oversee documentation related to process development, qualification, and validation to meet regulatory requirements.

• Author and review process-related documents including risk assessments, technical protocols and reports, batch records, change controls, investigation reports, and corrective and preventive actions (CAPAs).

• Author and review CMC sections of regulatory submissions supporting clinical trial applications (IND/IMPD) and commercial applications (BLA/MAA).

• Develop and implement plans and studies required to incorporate new technologies that support the mission and pipeline needs of the organization.

• Plan and oversee studies supporting process development, process characterization, and lifecycle change management to ensure timely and complete delivery aligned with development timelines.

• Serve as the accountable technical interface between Kyverna Process Development and CDMO partners to manage process development and process characterization activities supporting engineered cell-based therapy programs.

• Support CMC and product development teams through robust data analysis, process development execution, and integration of manufacturing and development strategies within CMC functions.

• Maintain current awareness of GMP/GTP regulations, guidance documents, advisory committee updates, industry standards, and emerging trends relevant to Cell Therapy Development operations and products.

• Establish and maintain strong cross-functional partnerships with Analytical Development, Manufacturing, Quality, Clinical, and Regulatory teams.

Requirements

• Advanced degree in Cell Biology, Immunology, Molecular Biology, Chemical Engineering, Biotechnology, or a related field; PhD preferred.

• 10+ years of experience in pharmaceutical manufacturing, technology transfer, and process development.

• Proven expertise in CAR-T or other ex vivo gene-modified cell therapy process development, including process characterization, technology transfer, and comparability assessments.

• Experience is in CAR-T or similar ex-vivo lenti-transduced cell therapy products

• Experience advancing product development on closed automated platforms, or practical experience applying process automation in support of cell therapy processes, preferred.

• Established track record supporting both early- and late-stage CMC and clinical product development programs.

• Strong expertise in cGMP manufacturing and associated pharmaceutical regulatory requirements.

• Knowledge and experience in late-stage development and implementation of process improvements in a post approval setting is preferred.

• Excellent interpersonal, verbal, and written communication skills.

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

• Ability to foster a collaborative, team-first culture that supports achievement of company objectives.

• Demonstrated success leading high-performing development teams and developing talent.

• Demonstrated ability to think creatively and solve complex technical and operational challenges.

• Ability to collaborate and communicate effectively with Kyverna leadership, Analytical Development, Manufacturing, Quality, Clinical, and Regulatory teams, as well as external partners and regulatory authorities.