Sr. Associate Manufacturing Engineer

Role Overview

The Sr. Associate Manufacturing Engineer will be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Will participate and assist in technical transfer activities into and out of the Raritan facility. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

Key Responsibilities  

• Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan facility.
• Support and identify opportunities for process improvements, support improvement projects, and drive implementation strategy. Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Write and/or review manufacturing process transfer plans, protocols, and reports.
• Design studies, draft protocol, oversee execution and draft reports necessary to support the implementation of process improvements.
• Provide technical/scientific recommendations and support and manage applicable change controls.
• Technical assessor of change controls.
• Provide review of process flow diagrams as well as protocol and reports from development.
• Support the implementation of manufacturing and process improvement strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products.
• Work closely with cross-functional teams to design and implement cell therapy processes for cell therapy platforms.
• Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms and/or new raw materials and consumables for cell therapy development and manufacturing.
• Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.
• Draft Process Risk Assessments for implementation of process changes.

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required.
• Advanced degree preferred.
• 5 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Support facility fit assessments for evaluation of changes between sending and receiving sites.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of technical transfer activities and/or process improvements.
• Work closely with the development organization to ensure translation of changes from concept to implementation.
• Support writing of MBRs and SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Provide technical expertise in the evaluation of potential process changes for effectiveness, value, and risk.
• Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.

#Li-JT1

#Li-Onsite