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Associate Scientist / Scientist, MS&T

Philadelphia, PA

About the Position

The Associate Scientist or Scientist, MS&T will be responsible for supporting and directing product candidates through cGMP process development and support 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 weekend and overtime work.

Responsibilities Include

  • Support the transfer of process to CMO for early phase cGMP clinical manufacturing.
  • Execute process development experimental plans, provide associated protocols and final reports as needed, and 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.
  • Support phase-appropriate cell therapy production processes using QBD principles.
  • Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality.
  • Support CMO manufacturing operation oversight, including data capture, batch record and testing form review, deviation investigation and CAPAs.
  • Coordinate with internal groups and external partners, scheduling and tracking clinical patient material/product shipping and receiving, troubleshooting associated issues.
  • Support shipping and receiving investigational material and samples for pre-clinical, clinical and development projects.
  • Maintain laboratory material and sample inventory, support the planning of MS&T process development materials needs and coordinate purchasing with lab manager.

Required Qualifications

  • B.S. with 5 + years or M.S. with 2 – 5 + years’ experience within biologics process development and manufacturing under cGMP processes. Title will be evaluated by applicants experience level.
  • 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 preferred.
  • Experience in flow cytometry and cell-based bioassays is a plus.
  • Good working knowledge in cGMP manufacturing of biological process and ICH regulations is required.
  • 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.