Chief Technology Officer (CTO)

Location United States of America
Job type: Permanent
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 619-369-2875
Job ref: 1234568b
Published: 3 months ago
Expiry date: 17 Aug 2024 23:59

​▪ PhD in Chemical Engineering or equivalent
▪ >20 years experience in industry with >10 years in RNA or related fields
▪ Experienced with strong collaboration across R&D
▪ Experienced building teams across multiple functions and with taking technologies from
discovery stage through to clinical development
▪ Highly experienced in technology development in clinical development
▪ Strong network in RNA and / or nanoparticle development
▪ Strong, clear experience in strategic management, planning and execution.

Build team to oversee tech development / scale-up across both delivery technologies and RNA
modalities.
• Define & execute CMC strategy to support IND filings and clinical trials including selection of
CDMO.
• Establish analytical team to characterize Drug Substance and Drug product for materials used in
pre-clinical or IND enabling studies.
• Establish Quality systems and processes to support development activity.
• Identification and evaluation of new technologies to ensure operational success.
• Provide functional and executive leadership of manufacturing strategy.
• Establish long term supply chain strategy which may include in-house capabilities and /or
acquisition of technologies and infrastructure.
• Develop effective and efficient working relationships with both internal and external partners.
• Work closely with Regulatory to develop and implement CMC related Regulatory strategy.
• Work closely with external manufacturing partners to ensure reliable, compliant execution
against production schedules to meet company and program goals.
• Oversee the implementation and ongoing support of compliant cGMP manufacturing processes
at raw material, drug substance, and drug product manufacturing sites.
• Ensure performance of manufacturing sites in process validation and inspection readiness
activities.
• Drive continued improvement and operational excellence at CMOs to maintain a high level of
compliance and efficiency to world-class manufacturing standards.
• Lead Life Cycle Management of specialty raw material and commercial manufacturing processes
to meet the needs of program and CMC team requirements.
• Ensure CMO and internal compliance with cGMP and all related elements such as facilities,
documentation (SOPs and validation protocols etc.), training, reports and records.