Associate Scientist, Process Development

The Associate Scientist, Process Development (PD) will be responsible for refinement, development, and assist in transfer of product candidates through to Cabaletta's cell therapy CDMOs. This position will work very closely with internal stakeholders (e.g. MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners, and require up to 10% domestic travel or occasional weekend and overtime work. Responsibilities: Execute process development experimental plans, provide associated protocols and final reports as needed, and present updates and data to teams. Design and execute Design of Experiments (DoE) studies to support process improvement, process characterization, and evaluate their impact on critical quality attributes (CQAs) and process performance. Support phase-appropriate cell therapy production processes using QbD principles. Assist the transfer of process to CDMOs for cGMP clinical manufacturing. Develop and review electronic Batch Records (eBRs) to support clinical manufacturing, ensuring alignment with process requirements, manufacturing procedures, and GMP expectations. Accurately capture data in a timely manner, ensuring data integrity and protocol compliance. Maintain all individual training requirements in a compliant state. Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality. Coordinate with internal groups and external partners, scheduling and tracking clinical patient material/product shipping and receiving, troubleshooting associated issues. Maintain laboratory material and sample inventory, support the planning of MS&T process development materials needs and coordinate purchasing with lab manager. Qualifications: