Process Engineer, Manufacturing Science & Technology (MSAT)

 

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

 

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

 

Position Description:               

 

This role is located in Center City, Philadelphia and will require travel up to approximately 10%.

As we move our cell therapy programs through late-stage development toward BLA submission and commercial readiness, we are seeking a Process Engineer to join our MSAT organization and drive the technical rigor required for scalable, compliant manufacturing. In this role, you will support process optimization, technology transfer, process characterization, and data-driven troubleshooting to ensure robustness and consistency across our production platforms. If you’re motivated by complex technical challenges and the opportunity to shape processes that will ultimately reach patients, this is an ideal next step in your career.

 

Responsibilities

 

  • Support technology transfer of mature, optimized processes to CMOs for clinical and late-phase cGMP manufacturing, ensuring readiness for PPQ and commercial-scale operations.
  • Provide manufacturing oversight at CMOs, including person-in-plant support, review of manufacturing performance, and real-time issue escalation to maintain phase-appropriate control strategies.
  • Execute process development and characterization studies, generate high-quality protocols and reports, and present data to cross-functional teams to inform PPQ planning and BLA Module 3 content.
  • Ensure timely and accurate data capture, supporting data integrity requirements for late-stage filings, validation packages, and regulatory inspections.
  • Maintain all training requirements in a compliant state, aligning with expectations for late-stage manufacturing and inspection readiness.
  • Support phase-appropriate cell therapy processes using QbD principles, including identification of CPPs/CMAs and contributing to control strategy refinement for BLA submission.
  • Identify and evaluate new technologies that enhance scalability, robustness, cost efficiency, and process consistency in preparation for commercial readiness.
  • Provide ongoing oversight of CMO operations, including batch record and testing documentation review, data trending, and deviation/CAPA support consistent with PPQ and late-stage expectations.
  • Coordinate internal and external activities related to patient material and product logistics, ensuring compliant chain-of-identity/chain-of-custody processes critical for pivotal trial operations.
  • Support MSAT planning for development and validation materials, maintaining inventory and coordinating procurement to enable process characterization and PPQ readiness.
  • Execute routine and established laboratory procedures, including assays, cell culture, and analytical tests that feed into process understanding, comparability, and validation efforts.
  • Collect, analyze, and summarize data, monitor for atypical trends, and contribute to data packages used for late-stage decision-making and regulatory submissions.
  • Perform basic statistical data analysis, supporting trending, process capability assessments, and characterization summaries with increasing independence.
  • Other related duties, as assigned.

 

Qualifications:                                           

  • B.S. with 3 + years or M.S. with 2-3 years' experience within biologics process development, MSAT or manufacturing under cGMP processes or PhD degree.
  • Previous experience and working knowledge of T-cells or immunological cell therapies.
  • Ability to travel up to 10%
  • Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required.
  • Experience supporting late-stage MSAT activities, including process characterization, PPQ planning/execution, scale-up/scale-out strategies, and continued process verification.
  • Direct involvement in BLA-enabling MSAT deliverables such as Module 3 process descriptions, validation packages, tech transfer documentation, and inspection readiness strongly preferred.
  • Experience in flow cytometry and cell-based bioassays is a plus.
  • Experience of cold chain logistics is preferred.
  • Good working knowledge in cGMP manufacturing of biological process and ICH regulations.
  • Strong written and verbal communication skills.
  • Highly organized and efficient.
  • Able to work independently.
  • Strong problem-solving skills.
  • Able to coordinate and prioritize parallel tasks across multiple projects.
  • Strong team orientation and passion for continuous self-development.
  • Experience in the biotech industry or in a startup industrial setting is preferred.

 

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-ONSITE