Process Engineer, Process Development
Kyverna Therapeutics
Emeryville, CA, USA
Posted on May 5, 2026
Responsibilities
- Lead design, optimization and technical execution of process development activities for autologous CAR T cell workflows (cell isolation, activation, transduction/transfection, expansion, harvest, formulation, cryopreservation).
- Develop and implement automated formulation and fill/finish processes for cell therapy drug product, including closed-system and aseptic considerations.
- Support the integration and validation of robotics platforms with cell processing steps as process subject matter expert.
- Design experiments, run bench- and pilot-scale studies, maintain accurate lab notebook entries, analyze data, and generate technical reports.
- Draft and maintain process documentation including process descriptions, process control strategies, bill of materials, and standard operating procedures.
- Maintain accurate documentation (protocols, batch records, risk assessments, CAPAs) consistent with regulatory and GMP standards.
- Support technology transfer to MSAT and manufacturing, including development of manufacturing instructions, equipment requirements, training materials, and execution support.
- Work with analytical development and quality control to define in-process controls, release testing, and associated acceptance criteria.
- Support equipment qualification, process validation, and troubleshooting in GMP environments.
- Participate in cross-functional project teams and present technical updates to stakeholders.
Qualifications
- BS in Chemical, Biomedical, Biological Engineering, or related field and 8 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferred.
- MS in Chemical, Biomedical, Biological Engineering, or related field (MS preferred) and 6 years experience in process development for cell therapy products; direct experience with autologous CAR T highly preferred..
- Practical experience designing and executing cell culture/expansion and formulation processes for cell therapy drug products.
- Hands-on experience with automation of formulation and fill/finish steps; familiarity with closed-system processing and aseptic fill technologies.
- Knowledge of GMP requirements, technology transfer practices, and manufacturing support (MSAT).
- Strong data analysis skills and proficiency with experimental design, statistical analysis, and process characterization.
- Excellent technical writing skills for protocols, reports, and process transfer packages.
- Experience with specific automated platforms (e.g., CliniMACS Prodigy, CTS Rotea, CTS Compleo, GatheRex, GE WAVE, Dynaselect) or robotic solutions.
- Experience integrating robotics and automation systems (e.g., liquid handlers, robotic arms, automated incubators/bioreactors) into bioprocess workflows.
- Strong problem-solving and troubleshooting capability in laboratory and pilot-scale environments.
- Collaborative team player with demonstrated ability to work cross-functionally with MSAT, manufacturing, analytical, QA, and RegCMC.
- Effective communicator—able to present complex technical concepts clearly to scientific and non-scientific stakeholders.
- Organized, detail-oriented, able to manage multiple priorities and project timelines.
- Comfortable working in dynamic, fast-paced biotech environments.