Associate Scientist, Process Development
Cabaletta Bio
August 13, 2026
On-site
Philadelphia, PA
Operations
About the Position:
The Associate Scientist, Process Development (PD) will refine, develop, and assist in transferring product candidates to Cabaletta’s cell therapy CDMOs. Works closely with internal stakeholders (MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners; requires up to 10% domestic travel and occasional weekend/overtime work.
Responsibilities:
- Execute process development experimental plans; generate protocols and final reports; present updates/data.
- Design and execute Design of Experiments (DoE) to support process improvement/characterization and evaluate impacts on critical quality attributes (CQAs) and process performance.
- Support phase-appropriate cell therapy production processes using QbD principles.
- Assist process transfer to CDMOs for cGMP clinical manufacturing.
- Develop and review electronic Batch Records (eBRs) aligned with process requirements, manufacturing procedures, and GMP expectations.
- Capture data timely and accurately, ensuring data integrity and protocol compliance.
- Maintain training requirements in a compliant state.
- Identify/evaluate new technologies to improve manufacturing outcomes (reduced costs, increased throughput, enhanced quality).
- Coordinate shipping/receiving of patient material/product and troubleshoot issues.
- Maintain lab material/sample inventory; support MS&T planning and coordinate purchasing with lab manager.
Required Qualifications:
- B.S. with 3+ years or M.S. with 1+ years in process development/manufacturing under cGMP.
- Working knowledge of T-cells/immunological cell therapies.
- Experience with cell therapy manufacturing scale-up, technology transfer, and process development/optimization.
- Good working knowledge of cGMP biological manufacturing and ICH regulations.
- Strong coordination/communication; highly organized; able to work independently; strong problem-solving.
- Ability to coordinate parallel tasks across multiple projects with prioritization.
Preferred Qualifications:
- Experience in process automation.
- Experience in flow cytometry and cell-based bioassays.
The Associate Scientist, Process Development (PD) will refine, develop, and assist in transferring product candidates to Cabaletta’s cell therapy CDMOs. Works closely with internal stakeholders (MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners; requires up to 10% domestic travel and occasional weekend/overtime work.
Responsibilities:
- Execute process development experimental plans; generate protocols and final reports; present updates/data.
- Design and execute Design of Experiments (DoE) to support process improvement/characterization and evaluate impacts on critical quality attributes (CQAs) and process performance.
- Support phase-appropriate cell therapy production processes using QbD principles.
- Assist process transfer to CDMOs for cGMP clinical manufacturing.
- Develop and review electronic Batch Records (eBRs) aligned with process requirements, manufacturing procedures, and GMP expectations.
- Capture data timely and accurately, ensuring data integrity and protocol compliance.
- Maintain training requirements in a compliant state.
- Identify/evaluate new technologies to improve manufacturing outcomes (reduced costs, increased throughput, enhanced quality).
- Coordinate shipping/receiving of patient material/product and troubleshoot issues.
- Maintain lab material/sample inventory; support MS&T planning and coordinate purchasing with lab manager.
Required Qualifications:
- B.S. with 3+ years or M.S. with 1+ years in process development/manufacturing under cGMP.
- Working knowledge of T-cells/immunological cell therapies.
- Experience with cell therapy manufacturing scale-up, technology transfer, and process development/optimization.
- Good working knowledge of cGMP biological manufacturing and ICH regulations.
- Strong coordination/communication; highly organized; able to work independently; strong problem-solving.
- Ability to coordinate parallel tasks across multiple projects with prioritization.
Preferred Qualifications:
- Experience in process automation.
- Experience in flow cytometry and cell-based bioassays.