Join Our Crew

Responsibilities Include

• 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.

Required Qualifications

• 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.
• 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.

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