Chief Technology Officer (CTO)

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

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 6175951613
Job ref: 987uytr
Published: 28 days ago
Expiry date: 29 Feb 2024 23:59

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.