Technology Transfer and Manufacturing Readiness
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.
Manufacturing Process Support and Technical Leadership
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.
Investigations and Root Cause Analysis
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.
Process Monitoring and Continuous 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.
Team Leadership and Cross-Functional Collaboration
Manage and develop MSAT staff while remaining connected to the underlying science and process details.
Translate priorities into clear projects, owners, deliverables, timelines, decisions, and accountability while balancing support, transfer, monitoring, and improvement work.
Balance and prioritize technology transfer, investigation, monitoring, and improvement activities across the MSAT portfolio.
Maintain visibility into the MSAT portfolio and communicate project status, risks, resource needs, and priorities to leadership.
Act as a key liaison across Manufacturing, Quality, Development, Regulatory, Supply Chain, Commercial, and other functions.
Communicate technical findings, risks, tradeoffs, recommendations, and project updates clearly to technical teams, leaders, customers, and executives.
Documentation, Compliance, and Regulatory Support
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.
