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Senior Scientist / Principal Scientist, MS&T

Philadelphia, PA

About the Position

Reporting to the Director of MS&T, the Sr Scientist/Principal Scientist, MS&T will be responsible for directing product candidates through cGMP process development and lead technology transfer to Cabaletta’s cell therapy CMO. This position will work very closely with manufacturing partners and require up to 10% domestic travel and the potential for occasional overtime work.

Responsibilities Include

  • Lead or 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.
  • Lead the development of phase-appropriate cell therapy production processes using QBD principles.
  • Oversee development activities for 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: reduce costs, throughput, and quality.
  • Contribute to regulatory filings as needed for IND and future BLA submissions.
  • Oversee CMO manufacturing operations, including data capture, batch record and testing form review, deviation investigation and CAPAs.

Required Qualifications

  • D. in Biological Sciences or related fields with 3 to 6 + years’ experience working within biologics process development and manufacturing under cGMP processes.
  • Previous experience and working knowledge of T-cells or immunological cell therapies.
  • Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization are required.
  • Experience with gene modified T cell products (CAR-T, TCR).
  • 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.
  • Highly organized and efficient, able to work independently. Strong problem-solving skill is preferred.
  • Ability to coordinate parallel tasks across multiple projects, demonstrating 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.