Chief Technology Officer (CTO)

Location United States of America
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 6175951613
Job ref: 79854333468
Published: 21 days ago
Expiry date: 01 May 2024 23:59

•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.