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.

Requirements

B.S. with 3 + years or M.S. with 1 + years’ experience within process development and manufacturing under cGMP processes; Previous experience and working knowledge of T-cells or immunological cell therapies; Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required; Good working knowledge in cGMP manufacturing of biological process and ICH regulations; Good coordination and communication skills are required; Highly organized and efficient, able to work independently; Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

Nice to have

Experience in process automation is a plus; Experience in flow cytometry and cell-based bioassays is a plus; Strong problem-solving skill is preferred.

Benefits

Health and retirement; PTO; stock option plans