Associate Scientist, Process Development

Cabaletta Bio · Philadelphia, PA · 2 wk ago

On-siteAnalystFull-time

About the Company

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies aimed at advancing the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy prioritizes the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology, and dermatology.

Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. The company is Great Place to Work-Certified™, fostering a culture focused on team success, employee well-being, and continuous growth.

About the Role

The Associate Scientist, Process Development (PD) will be responsible for refinement, development, and assisting in the transfer of product candidates to Cabaletta’s cell therapy CDMOs. This position requires close collaboration with internal stakeholders (e.g., MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners, and may involve 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 processes 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 the lab manager.

Requirements

B.S. with 3+ years or M.S. with 1+ years of 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.
Good working knowledge of cGMP manufacturing of biological processes and ICH regulations.
Strong coordination and communication skills.
Highly organized and efficient, able to work independently.
Strong problem-solving skills.
Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

Experience in process automation, flow cytometry, and cell-based bioassays is a plus.

Benefits