Senior Engineer, Process Sciences - Drug Product

Encoded Therapeutics is a clinical-stage genetic medicines company developing potentially disease-modifying therapies to improve the lives of people with severe CNS disorders. Our proprietary vector engineering approach combines novel regulatory elements and payloads with AAV vectors to unlock innovative solutions for debilitating, intractable CNS conditions. At the forefront is our flagship clinical program, ETX101 for Dravet syndrome, which targets the underlying cause of the disorder to enable highly selective upregulation of SCN1A for potentially long-lasting benefit. In parallel, we are advancing a pipeline of potentially best-in-class programs to address significant unmet needs across both monogenic and prevalent CNS conditions. For more information, please visit www.encoded.com.

We are recruiting a Senior Engineer, Process Sciences (Drug Product) to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment.

Responsibilities

• Serve as an engineer responsible for clinical, PPQ, and commercial Drug Product manufacturing for AAV products
• Lead internal and external Tech Transfer for Drug Product manufacturing
• Collaborate with cross-functional stakeholders to support URS development, vendor selection, FAT/SAT for internal Fill/Finish facility
• Collaborate with cross-functional stakeholders to develop CQV protocols and equipment validation strategies
• Provide person-in-plant support of GMP (clinical and commercial) manufacturing as required at internal and external sites of manufacturing
• Develop and maintain manufacturing performance trending tools
• Work with cross-functional teams to develop tools/templates to support tech transfer business processes
• Support regulatory filings and serve as technical SME during regulatory inspections