Sr. Process Engineer, Process Development

Philadelphia, PA 

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 Sr. Process Engineer will serve as a senior team member and project leader, focusing on process development, process assessment and continuous improvement in support of activities within process development, manufacturing, and product characterization of cell therapy products in the MS&T lab. This position works very closely with other team members within the MS&T group and requires occasional weekend and overtime work divided across the group. 

Responsibilities Include to: 

  • Support the transfer of process to CMO for early phase cGMP clinical manufacturing. 
  • Execute process development/scale up experimental plans including designing protocols and studies, evaluate process and assay data, investigate protocol deviations and acceptance criteria failures, and provide associated protocols and final reports. 
  • Accurately capture data in a timely manner, ensuring data integrity and protocol compliance. 
  • Manage developmental and manufacturing data and support development of database. 
  • Present data to teams on process development and manufacturing support activities. 
  • Support laboratory ELN/LIMS system set up. 
  • Support continuous process improvements and development for the manufacturing of drug products. 
  • Identify and evaluate innovation opportunities to improve manufacturing outcomes such as: cost reduction, throughput, and quality. 
  • Apply Quality by Design (QBD) principles to process development and characterization, and establish process parameters. Apply risk assessment throughout the process validation lifecycle. 
  • Contribute to, and review peer developed drafts of CMC sections of regulatory filings and other critical documents. 
  • Coordinate projects with cross-functional teams including Analytical Development, Quality Assurance, Translational Sciences, Gene Therapy, and Pre-Clinical. 
  • Maintain detailed and comprehensive project timelines and budgets. 
  • Serve as a mentor and leader for other lab and team members. 

Required Qualifications 

  • B.S. with 7 + years or M.S. preferred with 5 + years direct work experience in biologics process development, process validation, or manufacturing under cGMP processes and ICH regulations, with specific experience in cell and gene therapy products. Candidates with a Ph.D. in Biology, Chemistry, Biotechnology Sciences or Engineering with a minimum 2 + years direct work experience will also be considered. 
  • Experience and working knowledge of T-cells or immunological cell therapies 
  • Proven track record carrying out cell processing, scale up, and process development for GMP cell therapy product manufacturing. 
  • Experience contributing to preparation of documents for regulatory review, including but not limited to, INDs and BLAs. 
  • Experience of process validation lifecycle approach and risk assessments using a variety of tools, e.g. FMEA, HACCP. 
  • Knowledge and experience of aseptic process simulations. 
  • Highly organized and efficient, strong team orientation and passion for continuous self-development. 
  • Ability to manage and coordinate parallel tasks across multiple projects, prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment. 
  • Must be able to work well on cross-functional teams in a start-up environment, as well as perform independently 
  • Strong problem-solving and excellent technical writing and verbal communication skills are required. 

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 careers@cabalettabio.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 including health and retirement, 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.