Associate Director, Manufacturing

Encoded Therapeutics Job Opportunity

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches.

Responsibilities :

• Lead site start-up of internal manufacturing in partnership with Site head of operations (VP MFG / MSAT)
• Manage the manufacturing team for Encoded Therapeutics, reporting to the VP of Manufacturing (MFG) and Manufacturing Sciences and Technology (MSAT)
• Execute the manufacturing strategy, including identifying resource needs and the hiring and management of internal and contract employees
• Ensure successful delivery of GMP material, including oversight of production planning / scheduling adherence, manufacturing batch execution, manufacturing batch close out, and deviation management
• Provide real-time manufacturing campaign support for internal manufacturing
• Partner with Quality Assurance to ensure on-time creation and lifecycle management of manufacturing systems and procedures required for the Quality Management System
• Work with the VP of MFG / MSAT to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
• Provide operations support for equipment IQ, OQ, PQ activities, including procedure writing and provide operations input on internal equipment selection and deployment
• Ensure adherence to GxP guidelines as indicated by phase of manufacture