Associate Scientist, Process Development

About the role

Cabaletta Bio is recruiting an Associate Scientist, Process Development for its cell therapy business, based on-site in Philadelphia, PA. The scientist refines, develops and helps transfer product candidates to Cabaletta's cell therapy contract development and manufacturing organizations (CDMOs), working closely with internal stakeholders, external manufacturing partners and requiring up to 10% domestic travel or occasional weekend and overtime work.

Key responsibilities

• Execute process development experimental plans, write protocols and reports, and present updates and data to teams
• Design and run Design of Experiments (DoE) studies to support process improvement, characterize processes and evaluate impacts on critical quality attributes and performance
• Support phase-appropriate cell therapy production using QbD principles
• Assist transfer of processes to CDMOs for cGMP clinical manufacturing
• Develop and review electronic batch records (eBRs) aligned with GMP expectations
• Capture data accurately and in time, maintain training records, and identify new technologies to reduce costs, increase throughput and improve quality
• Coordinate shipping and receiving of clinical patient material and products, troubleshoot issues, and manage laboratory material and sample inventory

Required profile

• B.S. with 3+ years or M.S. with 1+ year of experience in process development and manufacturing under cGMP
• 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
• Good coordination and communication skills, highly organized and able to work independently

Required skills

• Good working knowledge of cGMP manufacturing of biological products and ICH regulations
• Plus: process automation, flow cytometry and cell-based bioassays

What we offer

• Health and retirement benefits
• PTO
• Stock option plans