Process Engineer, Manufacturing Science & Technology; MSAT

Role Summary

This role is located in Center City, Philadelphia and will require travel up to approximately 10%. As we move our cell therapy programs through late-stage development toward BLA submission and commercial readiness, we are seeking a Process Engineer to join our MSAT organization and drive the technical rigor required for scalable, compliant manufacturing. In this role, you will support process optimization, technology transfer, process characterization, and data-driven troubleshooting to ensure robustness and consistency across our production platforms.

• 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.

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

• Degrees as listed in Qualifications (B.S./M.S./PhD) in a relevant field.