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Senior Scientist / Principal Scientist, PD

Philadelphia, PA

About the Position

Reporting to the Director of PD/MS&T, the Sr Scientist/Principal Scientist, PD will be responsible for identifying, developing and supporting the implementation of new cGMP compliant processes and materials. This position will work very closely with MS&T.    Up to 10% domestic travel and the potential for occasional overtime work is anticipated.

Responsibilities Include

  • Design and execute process development experimental plans and provide associated protocols and final reports, present updates and data to teams.
  • Lead the design and execution of phase-appropriate process development studies using QBD principles to develop a thorough understanding of operation performance parameters for T cell manufacturing process.
  • Evaluate, develop and implement functionally closed systems for T manufacturing process.
  • 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.
  • Perform in-vitro cellular assays involving flow cytometry, cytotoxicity, and functional characterization of genetically engineered primary T cells
  • Contribute to regulatory filings as needed for IND and future BLA submissions.
  • Support the technology transfer of the manufacturing process to CMO for early phase cGMP clinical manufacturing, as assigned.
  • Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
  • Maintain all individual training requirements in a compliant state.

Required Qualifications

  • Ph.D. in Biological Sciences or related fields with 3 to 6 + years’ experience working within biologics process development and/or MS&T under cGMP processes.
  • Previous experience and working knowledge of T-cells or immunological cell therapies.
  • Experience with cell therapy manufacturing scale up, process development and process optimization are required.
  • Experience with functionally closed systems or early technology evaluations for large-scale autologous or allogenic CAR-T cells processing are highly desirable.
  • Experience with cell-based functional assays using engineered and/or primary human cells are preferred.
  • 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.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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.