Director, Process Development
Kyverna Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Emeryville • California • United States
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Job Level
About the role
- 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.
- 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 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.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process developmentprocess optimizationtechnology transferGMP manufacturingprocess characterizationrisk assessmentsprocess control strategiesdata analysiscell therapyprocess automation
Soft Skills
leadershipcollaborationresults-driven mindsetinterpersonal skillscommunication skillsindependent workteam-first culturecreative thinkingproblem-solvingmentoring