Associate Scientist, Process Development — Cell Therapy & Transfer

Cabaletta Bio Inc.; Philadelphia (Philadelphia County); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits

PTO

Stock options

Descripción de la vacante

Cabaletta Bio Inc. in Philadelphia, PA is seeking an Associate Scientist, Process Development to refine and transfer cell therapy processes. You will collaborate with MSAT, Analytical Development, QA, Regulatory, and external partners, with up to 10% travel and occasional overtime.

You will execute DoE studies, support DoE-driven improvements, and help transfer processes to CDMOs for clinical manufacturing, ensuring GMP compliance and data integrity throughout.

Formación

• B.S. with 3+ years or M.S. with 1+ years’ experience within process development and manufacturing under cGMP processes.
• Experience with T-cells or immunological cell therapies or related fields is preferred.
• Experience in cell therapy manufacturing scale-up and technology transfer is required.
• Experience in process automation and flow cytometry/ cell-based bioassays is a plus.
• Good knowledge of biologics GMP and ICH regulations, and strong coordination skills.

Responsabilidades

• Execute process development plans, provide protocols and reports, and present data to teams.
• Design and run DoE studies to improve processes and evaluate CQAs and performance.
• Support phase-appropriate cell therapy production using QbD principles.
• Assist transfer of processes to CDMOs for GMP clinical manufacturing.
• Develop and review electronic Batch Records (eBRs) for clinical manufacturing.
• Capture data timely with data integrity and protocol compliance.
• Maintain training requirements in a compliant state.
• Identify new technologies to improve costs, throughput, and quality.
• Coordinate with internal/external groups for shipping/receiving patient material.
• Manage laboratory material inventory and assist MS&T material planning with purchasing.

Conocimientos

Process development

cGMP manufacturing

Coordination

Communication

Independent work

Educación

Bachelor's degree

Master's degree

Descripción del empleo

Cabaletta Bio Inc. in Philadelphia, PA is seeking an Associate Scientist, Process Development to refine and transfer cell therapy processes. You will collaborate with MSAT, Analytical Development, QA, Regulatory, and external partners, with up to 10% travel and occasional overtime.

You will execute DoE studies, support DoE-driven improvements, and help transfer processes to CDMOs for clinical manufacturing, ensuring GMP compliance and data integrity throughout.