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Synthego is seeking a Manager of Manufacturing Science and Technology (MSAT) to lead critical manufacturing operations, technology transfer, and process improvement initiatives in a regulated biotechnology environment focused on CRISPR cell and gene therapies.
In this role, you will manage and develop the MSAT team while maintaining deep technical engagement with manufacturing science and process details. You will lead technology transfers from Development into Manufacturing, managing plans, timelines, milestones, risks, and readiness criteria. You'll serve as the primary technical resource for manufacturing operations, active orders, process execution, and quality control results, maintaining close connection to floor activities and providing technical leadership across products, scales, and unit operations.
Key responsibilities include leading investigations of process non-conformances, out-of-specification results, and manufacturing failures using structured root cause analysis; developing effective corrective actions with Operations and Quality teams; and identifying recurring patterns and systemic issues. You will monitor manufacturing health through trends in yield, purity, rework, process loss, QC performance, cycle time, and schedule risk, maintaining comprehensive understanding of manufacturing performance and technical risks.
You will lead product and process reviews, manage prioritized improvements to robustness, quality, cost, cycle time, throughput, and reliability, and provide concise reports to the Director of Manufacturing on findings, risks, recommendations, and actions. Cross-functional collaboration is essential—you'll act as a key liaison across Manufacturing, Quality, Development, Regulatory, Supply Chain, and Commercial functions, translating priorities into clear projects with defined owners, deliverables, timelines, and accountability.
Additional responsibilities include authoring and reviewing technical protocols, reports, risk assessments, process descriptions, and regulatory support content; capturing technical knowledge and lessons learned; and ensuring MSAT activities comply with GMP requirements and company quality systems.
Requirements:
- Bachelor's degree in engineering, chemistry, biochemistry, molecular biology, biotechnology, or related field; advanced degree preferred
- Relevant experience in regulated biotechnology, pharmaceutical, or biopharmaceutical manufacturing environment, including GMP operations
- Experience with technology transfer, technical investigations, process monitoring, process improvement, and cross-functional project leadership
- Demonstrated technical leadership or people-management experience
- Demonstrated ability to break complex manufacturing challenges into manageable components, identify underlying problems, and develop practical solutions based on data and first-principles thinking
- Strong technical judgment, data analysis, program management, problem-solving, documentation, and communication skills
