Scientist, Process Development

Philadelphia, PA



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

• 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

Qualifications:

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

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.

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