Manager, MSAT

The Manager, Manufacturing Science and Technology (MSAT) leads day-to-day MSAT activities supporting Synthego manufacturing operations. This role is the technical and operational lead for technology transfer, process performance, manufacturing investigations, continuous improvement, and manufacturing readiness. 

The Manager maintains detailed knowledge of manufacturing processes, active orders, QC results, technical risks, and the MSAT project portfolio. Working across Manufacturing, Quality, Development, Regulatory, Supply Chain, and Commercial, this person leads execution, develops evidence-based recommendations, and communicates key findings, risks, and proposed actions to the Director of Manufacturing. 

Lead technology transfers from Development into Manufacturing, managing plans, timelines, milestones, risks, deliverables, owners, and readiness criteria.

Coordinate cross-functional execution of manufacturing processes, equipment, and technology transfer activities to support company objectives.

Lead manufacturing readiness activities for new products, processes, and technologies.

Maintain detailed knowledge of transfer status and risks, develop mitigation plans, and escalate concerns with clear recommendations. 

Serve as the primary MSAT resource for detailed technical questions about manufacturing operations, active orders, process execution, and QC results.

Maintain close connection to floor activities and provide technical leadership and troubleshooting across products, scales, and unit operations.

Partner with Manufacturing, QA, and QC to assess how process conditions affect quality, schedule performance, process loss, and rework and to determine practical responses. 

Lead or oversee investigations of process non-conformances, out-of-specification results, manufacturing failures, and other production issues using structured, evidence-based root cause analysis.

Develop effective corrective actions with Operations and Quality, ensure investigations and improvement efforts address the correct underlying problem rather than symptoms, and evaluate findings across products, processes, and events to identify recurring patterns, systemic issues, and opportunities for broader process improvement. 

Monitor manufacturing and process health through trends in yield, purity, rework, process loss, QC performance, cycle time, and schedule risk.

Maintain a comprehensive understanding of manufacturing performance, technical risks, process capability, and emerging operational trends.

Identify recurring problems, process drift, emerging risks, and differences among products and manufacturing paths; develop useful leading indicators.

Evaluate technical findings, process trends, and manufacturing performance data to develop recommendations that improve quality, throughput, robustness, and manufacturing readiness.

Lead product and process reviews and manage prioritized improvements to robustness, quality, cost, cycle time, throughput, and reliability.

Provide concise reports to the Director of Manufacturing covering findings, risks, recommendations, actions, and unresolved questions. 

Author and review technical protocols, reports, risk assessments, process descriptions, transfer documents, and regulatory support content.

Capture and maintain technical knowledge, lessons learned, and best practices to support future technology transfers, investigations, and process improvements.

Ensure MSAT activities comply with GMP requirements and company quality systems, and support audit and inspection readiness. 

Bachelor’s degree in engineering, chemistry, biochemistry, molecular biology, biotechnology, or a related field; advanced degree preferred. 

Relevant experience in a 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 the correct underlying problem, and develop practical solutions based on data and first-principles thinking. 

Strong technical judgment, data analysis, program management, problem-solving, documentation, and communication skills. 

Synthego is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to best-in-class CRISPR solutions at scale, empowering agility in life science research and development from discovery through clinical trials. From streamlined approaches to licensing through full technical and regulatory support from our industry-leading experts, Synthego is enabling greater access to CRISPR technology driving to improved outcomes in patient therapeutic treatments.