Cabaletta Bio is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Cabaletta’s therapeutic platform produces highly selective autologous Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The platform is based on the revolutionary Chimeric Antigen Receptor (CAR) T cell technology developed at the University of Pennsylvania that resulted in one of the first commercially-available CAR T cell products for the treatment of B cell malignancies. Cabaletta has an exclusive global licensing agreement and multiple sponsored research agreements with the University of Pennsylvania to develop the CAAR T technology to treat B cell-mediated autoimmune diseases. The Company’s lead therapeutic program is a potential treatment for a prototypical B cell-mediated autoimmune disease, mucosal pemphigus vulgaris (mPV), which is a rare skin disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects.
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew
About the Position
Reporting to the Associate Director of MS&T, the Scientist / Senior Scientist, MS&T will be responsible for directing product candidates through cGMP process development and support technology transfer to Cabaletta’s cell therapy CMO. This position will work very closely with manufacturing partners and require up to 10% domestic travel or occasional weekend and overtime work.
Responsibilities to Include:
- Support the transfer of process to CMO for early phase cGMP clinical manufacturing.
- Design and execute process development experimental plans and provide associated protocols and final reports, present updates and data to teams.
- Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
- Maintain all individual training requirements in a compliant state.
- Develop phase-appropriate cell therapy production processes using QBD principles.
- Develop platform production processes and ensure processes are suitable for early and late-stage cGMP clinical development and commercialization.
- Identify and evaluate new technologies to improve manufacturing outcomes such as: reduce costs, throughput, and quality.
- Contribute to regulatory filings as needed.
- Oversee CMO manufacturing operations, including data capture, batch record and testing form review, deviation investigation and CAPAs.
- Coordinate with internal groups and external partners, scheduling and tracking clinical patient material/product shipping and receiving, troubleshooting associated issues.
- Support shipping and receiving investigational material and samples for pre-clinical, clinical and development projects.
- Coordinate with external plasmid and vector CMOs, tracking the timeline of production, releasing and shipping, to ensure the supply for clinical trials.
- Ph.D. in Biological Sciences or related fields with 1 + years’ experience working within biologics process development and manufacturing under cGMP processes.
- B.S. with 5 + years or M.S. with 3 + years’ experience within biologics 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.
- Experience in flow cytometry and cell-based bioassays is a plus.
- Experience of cold chain logistics is highly preferred.
- 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. Strong problem-solving skill is preferred.
- Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.
Our name – Cabaletta – is derived from the operatic term for the second part of an aria that is designed to highlight the technical expertise of the lead singer. While our company is not the first to develop chimeric T cells as therapies, we are the first to develop them in a way that leverages T cells to specifically eliminate only B cells that cause disease, while sparing healthy B cells. Utilizing the backbone of this core technology, we expect to advance our portfolio with a rapid and repetitive rhythm, similar to the rhythm that is typical of a cabaletta.
For more information, please visit https://www.cabalettabio.com/ or email email@example.com directly to submit an application. Please include your CV along with the title of the position you are applying for.
Our most important asset is our people and we offer competitive benefits, PTO, and stock option plans.
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.