Cabaletta Bio (NASDAQ: CABA) is focused on the discovery and development of T cell therapies for B cell-mediated autoimmune diseases. Our proprietary technology utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to precisely bind and destroy only specific autoantibody-expressing B cells while sparing normal antibody-expressing B cells, which are essential for human health. Cabaletta’s Approach for selective B cell Ablation platform, called our CABA™ platform, has applicability across more than two dozen B cell-mediated autoimmune diseases that we have identified, reviewed and prioritized. CAAR T technology 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 CAAR T technology to treat B cell-mediated autoimmune diseases.
The Company’s lead product candidate, DSG3-CAART, received IND clearance from the FDA in September 2019. DSG3-CAART is designed to be a potential treatment for patients with mucosal pemphigus vulgaris (mPV), which is a rare autoimmune blistering disorder that causes painful blisters and sores on mucous membranes leading to severe and sometimes debilitating and life-altering effects. The Company is expected to begin clinical trials for the lead compound for mPV in 2020. Cabaletta Bio is also pursuing a second product candidate, MuSK-CAART, designed to treat patients with MuSK-positive Myasthenia Gravis.
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, Process Development 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 include to:
- Develop phase-appropriate cell therapy production processes using QBD principles.
- Support the transfer of process to CMO for early phase cGMP clinical manufacturing.
- Develop platform production processes and ensure processes are suitable for early and late-stage cGMP clinical development and commercialization.
- Identify and evaluate innovation opportunities to improve manufacturing outcomes such as: reduce costs, throughput, and quality.
- Design and execute process development experimental plans and provide associated protocols and final reports.
- Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
- Maintain all individual training requirements in a compliant state.
- Oversee CMO manufacturing operations, including review batch record and testing forms.
- Work closely with the Director of GMP Quality Assurance to perform deviation investigations and CAPAs.
- Contribute to regulatory filings as needed.
- 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.
- Experience with cell therapy manufacturing scale up, technology transfer, and process development methods.
- Experience of basic biological laboratory techniques such as cell culture, PCR, cell-based bioassays, and/or ELISA. Extensive flow cytometry experience is required.
- 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.
- Good working knowledge in cGMP manufacturing of biological process and ICH regulations.
- Highly organized and efficient, with a curiosity to be part of cutting-edge science.
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 firstname.lastname@example.org 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 including a selection of medical, dental, vision plans, 401K match, transportation stipends, 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.