Our RESETTM clinical trials with rese-cel (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.

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Scientist, Process Development

About the Position

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.

Responsibilities Include

  • 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.

Required Qualifications

  • Bachelor’s Degree with 4+ years of experience, or Master’s Degree with 2+ years of experience, within biologics process development and manufacturing under cGMP processes.
  • Experience with cell therapy manufacturing scale-up, technology transfer, and process development methods is required.
  • Experience with basic biological laboratory techniques such as cell culture, PCR, cell-based bioassays, and/or ELISA.
  • Extensive experience in flow cytometry and cell-based assays is required.
  • Strong problem-solving skills are preferred.
  • Experience supporting regulatory documentation, including but not limited to INDs, CTAs, and BLAs.
  • Previous experience and working knowledge of T-cells or immunological cell therapies.
  • Good working knowledge of cGMP manufacturing for biological processes and ICH regulations.
  • Highly organized and efficient, with a curiosity for cutting-edge science.
  • Strong team orientation and a passion for continuous self-development.
  • Ability to coordinate parallel tasks across multiple projects, demonstrating strong prioritization skills.

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How to Apply

Please click the link at the bottom of the posting to submit an application.

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.