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.

Kyverna is hiring a Process Engineer, Process Development

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