Scientist, Process Development

Cabaletta Bio•Philadelphia, PA

2d•Onsite

About The Position

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance 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 is prioritizing 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. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role is located in Center City, Philadelphia. Reporting to the Associate Principal Scientist, Process Development, the Scientist, Process Development will lead the refinement, development, and characterization of cell therapy processes, and support the transfer of product candidates to Cabaletta’s external manufacturing partners (CDMOs). This role partners closely with cross-functional teams including MSAT, Analytical Development, Preclinical, Quality, CMC, and Regulatory to enable robust, scalable, and compliant manufacturing processes. The position may require up to 10% domestic travel, as well as occasional weekend or extended-hour support during critical activities such as tech transfer or manufacturing campaigns.

Requirements

Bachelors Degree with 4 + years experience or Masters Degree with 2 + years’ experience within biologics process development and manufacturing under cGMP processes.
Experience with cell therapy manufacturing scale up, technology transfer, and process development methods, scale-up, and tech transfer methods is required.
Experience of basic biological laboratory techniques such as cell culture, PCR, cell-based bioassays, and/or ELISA.
Extensive flow cytometry experience is required.in flow cytometry and cell-based assays.
Good working knowledge in cGMP manufacturing of biological process and ICH regulations.

Nice To Haves

Strong problem-solving skill is preferred.
Experience supporting documents for regulatory review including but not limited to INDs, CTAs, and BLAs.
Previous experience and working knowledge of T-cells or immunological cell therapies.
Highly organized and efficient, with a curiosity to be part of cutting-edge science.
Strong team orientation and passion for continuous self-development.
Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

Responsibilities

Design and execute process development experimental plans, author associated protocols and reports, and present data and insights to cross-functional teams.
Develop phase-appropriate cell therapy manufacturing processes using Quality by Design (QbD) principles.
Support technology transfer of processes to CDMOs for early-phase cGMP clinical manufacturing, as needed.
Contribute to the development of platform manufacturing processes and ensure readiness for clinical and future commercial manufacturing.
Identify and evaluate opportunities to improve manufacturing performance, including cost, throughput, robustness, and quality.
Maintain laboratory materials and sample inventory to support experimental planning and execution.
Accurately document experimental data in a timely manner, ensuring data integrity, traceability, and compliance with protocols.
Maintain individual training requirements in a compliant state.
Contribute to regulatory filings (e.g., IND/CTA) and technical documentation, as needed.
Other related duties, as assigned