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Scientist / Senior Scientist, MS&T

Philadelphia, PA

About the Position

Reporting to the Director of MS&T, the 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 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: reducing costs, increasing throughput, and enhancing quality.
  • Contribute to regulatory filings as needed.
  • Review development reports, tech transfer documents and batch records.
  • Oversee CMO manufacturing operations, including data capture, batch record and testing form review, deviation investigation and CAPAs.
  • Collaborate with internal teams and external partners, including effective cross-functional work to ensure success.
  • Support 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.    

Required Qualifications

  • D. in Biological Sciences or related fields with 3 + years’ experience working within biologics process development and manufacturing under cGMP processes.
  • S. with 7 + years or M.S. with 5 + years’ experience within biologics process development and manufacturing under cGMP processes.
  • Previous experience and working knowledge of T-cells or immunological cell therapies.
  • Significant experience in process development, optimization, scale-up and technology transfer of bioprocesses for the manufacture of cell therapy.
  • Knowledge and experience of the application of QbD principles, and in particular risk-based process development, a significant advantage.
  • Experience in flow cytometry and cell-based bioassays.
  • Good working knowledge in cGMP manufacturing of biological process and ICH regulations.
  • Good coordination and communication skills are required.
  • Scientific leadership skills and competencies, including the ability to supervise the work of other scientists within the laboratory, providing practical training and knowledge transfer to others.
  • Highly organized and efficient, able to work independently. Strong problem-solving skill is preferred.
  • Ability to coordinate parallel tasks across multiple projects, with effective prioritization.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

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.

About Cabaletta Bio

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, and initial safety data in clinical trials has been reported. 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. Cabaletta Bio is also pursuing additional pipeline candidates for other B cell mediated disorders including MuSK Myasthenia Gravis (MG) with an IND planned for 2H 2021, mucocutaneous PV, PLA2R positive membranous nephropathy (PMN), and Factor VIII inhibitors.

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