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Cabaletta Bio · 2 weeks ago

Process Engineer, Manufacturing Science & Technology (MSAT)

Philadelphia, PA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. They are seeking a Process Engineer in their MSAT organization to drive technical rigor for scalable manufacturing, supporting technology transfer, process optimization, and ensuring compliance for late-stage development.

BiotechnologyHealth CareMedicalRoboticsTherapeutics

Responsibilities

Support technology transfer of mature, optimized processes to CMOs for clinical and late-phase cGMP manufacturing, ensuring readiness for PPQ and commercial-scale operations

Provide manufacturing oversight at CMOs, including person-in-plant support, review of manufacturing performance, and real-time issue escalation to maintain phase-appropriate control strategies

Execute process development and characterization studies, generate high-quality protocols and reports, and present data to cross-functional teams to inform PPQ planning and BLA Module 3 content

Ensure timely and accurate data capture, supporting data integrity requirements for late-stage filings, validation packages, and regulatory inspections

Maintain all training requirements in a compliant state, aligning with expectations for late-stage manufacturing and inspection readiness

Support phase-appropriate cell therapy processes using QbD principles, including identification of CPPs/CMAs and contributing to control strategy refinement for BLA submission

Identify and evaluate new technologies that enhance scalability, robustness, cost efficiency, and process consistency in preparation for commercial readiness

Provide ongoing oversight of CMO operations, including batch record and testing documentation review, data trending, and deviation/CAPA support consistent with PPQ and late-stage expectations

Coordinate internal and external activities related to patient material and product logistics, ensuring compliant chain-of-identity/chain-of-custody processes critical for pivotal trial operations

Support MSAT planning for development and validation materials, maintaining inventory and coordinating procurement to enable process characterization and PPQ readiness

Execute routine and established laboratory procedures, including assays, cell culture, and analytical tests that feed into process understanding, comparability, and validation efforts

Collect, analyze, and summarize data, monitor for atypical trends, and contribute to data packages used for late-stage decision-making and regulatory submissions

Perform basic statistical data analysis, supporting trending, process capability assessments, and characterization summaries with increasing independence

Other related duties, as assigned

Qualification

Biologics process developmentCell therapy manufacturingTechnology transferProcess optimizationCGMP manufacturingFlow cytometryCell-based bioassaysTeam orientationCommunication skillsProblem-solving skillsOrganizational skills

Required

B.S. with 3 + years or M.S. with 2-3 years' experience within biologics process development, MSAT or manufacturing under cGMP processes or PhD degree

Previous experience and working knowledge of T-cells or immunological cell therapies

Ability to travel up to 10%

Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required

Experience supporting late-stage MSAT activities, including process characterization, PPQ planning/execution, scale-up/scale-out strategies, and continued process verification

Good working knowledge in cGMP manufacturing of biological process and ICH regulations

Strong written and verbal communication skills

Highly organized and efficient

Able to work independently

Strong problem-solving skills

Able to coordinate and prioritize parallel tasks across multiple projects

Strong team orientation and passion for continuous self-development

Preferred

Direct involvement in BLA-enabling MSAT deliverables such as Module 3 process descriptions, validation packages, tech transfer documentation, and inspection readiness strongly preferred

Experience in flow cytometry and cell-based bioassays is a plus

Experience of cold chain logistics is preferred

Experience in the biotech industry or in a startup industrial setting is preferred