Who we are looking for:

Vor Bio is seeking a Process Engineer to join the Manufacturing Science and Technology team. The Process Engineer will assist with the oversight of contract manufacturing organizations, internal manufacturing, and external vendors for successful delivery of drug product to clinical sites in support of Vor programs.

Key areas of responsibilities:

The Process Engineer will support the manufacturing and process development requirements by conducting technical studies, coordinating equipment and material logistics, and participating in the oversight as technical subject matter expert of manufacturing activities at external CMOs when required. Responsibilities include:

• Draft and review deviations, CAPAs, and Change Controls for clinical products
• Supervise process trainings during technical transfer of Vor processes
• Oversee execution Vor clinical manufacturing at external manufacturing organizations and ensures compliance to regulatory requirements
• Compile & analyze data, document results, and review manufacturing documentation.
• Utilizes data to implement process improvements
• Present manufacturing summary for CMC strategy team.
• Leads Tech Transfer activities for new products and processes.
• Lead comparability studies including the authoring of protocols and reports
• Review production protocols, master batch records, and standard operating procedures

Skills and requirements: 

• Bachelor’s degree in Engineering: mechanical and chemical engineering degrees preferred.
• 4-8 years of experience working in a pharmaceutical production facility; cell therapy experience preferred
• Good oral and written communication skills with an ability to work in cross-functional product development and manufacturing teams.
• Experience with cGMP requirements and clean room operations is a plus.