Chief Technology Officer (CTO)

·        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.