Director, Process Development

Kyverna Therapeutics•Emeryville, CA

10d•$210,000 - $235,000•Hybrid

About The Position

Kyverna is seeking a Director, Process Development to provide leadership for all Process Development activities supporting both clinical and commercial programs. The director will provide strategic level leadership to deliver new processes, process optimization/improvements as well as support ongoing manufacturing of CART cell therapies. The Director will lead a team of scientists and engineers in development of robust processes for the expansion of edited T-cells. The role will require strong partnership with functions inside of technical operations including Analytical, Quality, and Manufacturing as well provide process expertise to cross functional teams outside of Technical Operations. The role will provide technical input to processes at Third Party CMOs and assess the risks and potential opportunities associated with partnerships important to Kyverna.

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
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.
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.

Nice To Haves

Experience advancing product development on closed automated platforms, or practical experience applying process automation in support of cell therapy processes, preferred.
Knowledge and experience in late-stage development and implementation of process improvements in a post approval setting is preferred.

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.