Head of Tech Ops & CMC
Location | United States of America |
Job type: | Permanent |
Contact name: | Sam Murphy |
Contact email: | therealsammurphy@gmail.com |
Contact phone: | 619-369-2875 |
Job ref: | 3909544467889 |
Published: | about 2 months ago |
Expiry date: | 17 Aug 2024 23:59 |
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.
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