Head of Tech Ops & CMC

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• Proven leadership experience in manufacturing strategy, process development, and CMC management.

• Strong background in technology development and scale-up across RNA modalities.

• Expertise in establishing quality systems, analytical characterization, and regulatory compliance.

• Ability to build and lead high-performing teams and develop effective partnerships.

• Team Building: Assemble and lead a team to oversee technology development and scale-up across delivery technologies and RNA modalities.

• CMC Strategy: Define and execute CMC strategies to support IND filings and clinical trials, including the selection of CDMOs.

• Analytical Leadership: Establish a team to characterize Drug Substance and Drug Product for pre-clinical and IND enabling studies.

• Quality Systems: Develop and implement quality systems and processes to support development activities.

• Technology Evaluation: Identify and evaluate new technologies to ensure operational success.

• Manufacturing Leadership: Provide executive leadership for manufacturing strategy and long-term supply chain strategy, which may include in-house capabilities or acquisitions.

• Regulatory Strategy: Collaborate with Regulatory teams to develop and implement CMC-related regulatory strategies.

• Partnerships: Foster effective working relationships with internal and external partners, ensuring reliable, compliant execution against production schedules.

• Compliance and Improvement: Oversee compliant cGMP manufacturing processes, ensure manufacturing site readiness for process validation and inspections, and drive continuous improvement at CMOs.