Senior Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations

Responsibilities

• Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products
• Communicate Manufacturing Operations needs to the CMC team, and ensure high-quality and timely program deliverables (comparability and validation study completion, etc)
• Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites
• Implement proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites
• Provide technical oversight across cell therapy manufacturing lifecycle — from pivotal manufacturing technology transfer, process validation, commercialization, and post-approval
• Identify and implement process improvements that increase process robustness, cost of goods, plant throughput, and supply continuity
• Contribute to post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks
• Proactively identify and mitigate technical and operational risks; ensure standardization across sites and teams
• Lead global Change Controls and ensure timely implementation and compliance
• Contribute to authoring CMC sections of regulatory submissions — Pivotal INDa, BLA, MAA, and supplements—with high efficiency and optimal content
• Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations
• Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes
• Work in close partnership with:
• Late-Stage Process Development — provide MSAT input for process definition, improvements, and process characterization
• Site MS&T — partner to ensure timely implementation of process changes and improvements at the sites
• Quality — ensure process compliance and product quality standards
• Supply Chain — inform long-range supply planning and risk mitigation

Qualifications

• Education: B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.
• Experience: Ph.D. with 1+ years; OR M.S. with 5+ years, OR B.S. with 7+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas.
• Technical and hands-on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered.
• Background in GMP manufacturing operations and technology transfer. Experience in process validation and CPV desired.
• Experience in authoring CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
• High standards of quality, accountability, and urgency — with the resilience to thrive in a fast-paced cell & gene therapy field.