Associate Scientist, Process Development: Tell Me More

Cabaletta Bio; Philadelphia (Philadelphia County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Stock options

Job summary

Cabaletta Bio in Philadelphia is seeking an Associate Scientist, Process Development to refine, develop, and transfer processes for cell therapy candidates. You will collaborate with MSAT, Analytical Development, QA, Regulatory, and CDMOs, with travel up to 10% and potential overtime.

You will execute DoE studies, support QbD-driven production, and help ensure CGMP compliance and data integrity across batches.

Qualifications

• B.S. with 3+ years or M.S. with 1+ years in process development and manufacturing under cGMP.
• Experience with T-cells or immunological cell therapies.
• Experience in cell therapy manufacturing scale up and technology transfer.
• Good knowledge of cGMP biopharma manufacturing and ICH regulations.
• Strong coordination and communication skills; highly organized.

Responsibilities

• Execute process development experiments and report results to teams.
• Design and conduct DoE studies to evaluate CQAs and process performance.
• Support cell therapy production using QbD principles.
• Assist transfer of processes to CDMOs for clinical manufacturing.
• Develop and review eBRs to ensure GMP alignment.
• Capture data timely with integrity and protocol compliance.
• Maintain training compliance for manufacturing staff.
• Identify new technologies to reduce costs and increase throughput.
• Coordinate with internal groups and external partners for shipping samples.
• Manage laboratory material inventory and planning needs.

Skills

Coordination

Communication

Problem-solving

Independent work

Education

B.S. or M.S. in a relevant field

Job description

Associate Scientist, Process Development

Philadelphia, PA, On-Site

About the Position

The Associate Scientist, Process Development (PD) will be responsible for refinement, development, and assist in transfer of product candidates through to Cabaletta’s cell therapy CDMOs. This position will work very closely with internal stakeholders (e.g. MSAT, Analytical Development, QA, Regulatory, supply chain), external manufacturing partners, and require up to 10% domestic travel or occasional weekend and overtime work.

Responsibilities Include

• Execute process development experimental plans, provide associated protocols and final reports as needed, and present updates and data to teams.
• Design and execute Design of Experiments (DoE) studies to support process improvement, process characterization, and evaluate their impact on critical quality attributes (CQAs) and process performance.
• Support phase-appropriate cell therapy production processes using QbD principles.
• Assist the transfer of process to CDMOs for cGMP clinical manufacturing.
• Develop and review electronic Batch Records (eBRs) to support clinical manufacturing, ensuring alignment with process requirements, manufacturing procedures, and GMP expectations.
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
• Maintain all individual training requirements in a compliant state.
• Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality.
• Coordinate with internal groups and external partners, scheduling and tracking clinical patient material/product shipping and receiving, troubleshooting associated issues.
• 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 3 + years or M.S. with 1 + years’ experience within 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 is required.
• Experience in process automation is a plus.
• Experience in flow cytometry and cell-based bioassays is a plus.
• 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.

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.